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Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry

Sponsor
ResMed (Industry)
Overall Status
Completed
CT.gov ID
NCT01500759
Collaborator
(none)
6,876
Enrollment
199
Locations
66
Duration (Months)
34.6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective target of the registry is to investigate the prevalence of SDB as well as the clinical characteristics of patients with and without SDB as well as the predominant type of sdb.

For this purpose data from patients suffering from chronic, symptomatic heart failure with impaired left ventricular ejection fraction will be collected prospectively.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Despite recent advances in pharmacological treatment, congestive heart failure (CHF) continues to cause debilitating symptoms, frequent hospital admissions and a high mortality. Despite of therapy with beta-blockers and ACE-inhibitors many patients have persistent symptoms and most will eventually die of cardiovascular causes, often from progressive heart failure.

    Sleep Disordered Breathing (SDB) is known to cause consequences, which have negative effects on heart failure.

    Objective target of the registry is to investigate the prevalence of SDB, clinical characteristics, symptoms and the degree and type of SDB in patients with chronic HF.

    For this purpose data from patients with chronic heart failure will be collected prospectively.In the registry several cardiologists in private practice or hospital and cooperating sleep laboratories shall participate.

    Cardiologists screen patients with Chronic Heart Failure (chronic HF) prospectively. In case of suffering from chronic HF for at least 12 weeks since diagnosis, with NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 12 months. Written informed consent for data privacy aspects must be obtained before screening for SDB. Patients who satisfy to all inclusion- and exclusion criteria will be included consecutively into the registry.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    6876 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure
    Study Start Date :
    Nov 1, 2007
    Actual Primary Completion Date :
    May 1, 2013
    Actual Study Completion Date :
    May 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of SDB in Chronic HF Patients [1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility]

      SDB= Sleep disordered breathing; HF= Heart failure

    Secondary Outcome Measures

    1. Left Ventricular Ejection Fraction [1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution]

      Amount of blood in the left ventricle at the end of Diastole that is being pumped into the System during systole

    2. Age [1-time single assessment at baseline]

      Age years

    3. Body Mass Index [1-time single assessment at baseline]

    4. Male Gender [1-time single assessment at baseline]

    5. NYHA Class ≥III [At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records]

      New York Heart Association Class III: Marked Limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in undue breathlessness, fatigue or palpitations.

    6. Ischemic Etiology [1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records.]

      Ischemic etiology describes a condition where a weakening or disease of the heart muscle is caused by reduced supply of blood (underlying cause might be the coronary artery). Secondary outcome ischemic etiology describes the cause of heart failure (HF) "ischemic" in HF patients without and with sleep-disordered breathing in percent of the respective study arm/group: e.g. x% of patients without SDB have HF with an ischemic etiology.

    7. Atrial Fibrillation [1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records]

    8. Nocturnal Dyspnea [1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records]

    9. Nocturia ≥3 Times/Night [1-time: At baseline nocturia was assessed 1 time (anamnesis)]

    10. Apnoea-Hypopnea-Index [1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility]

      Number of Apnoeas (cessation of airflow for at least 10 seconds) and hypopneas (reduced airflow for at least 10 seconds) per hours of sleep

    11. Oxygen Desaturation Index [1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility]

      Number of times that arterial blood oxygen saturation Drops by ≥3% from the Basic value.

    12. Mean SpO2 [1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility]

      Saturation of oxygen

    13. Min SpO2 [1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility]

      Lowest Saturation with oxygen

    14. Medication ACE Inhibitors and/ARBs [1-time: At baseline medication was assessed 1 time (anamnesis)]

      ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker

    15. Beta-blocker [1-time: At baseline medication was assessed 1 time (anamnesis)]

    16. Diuretics [1-time: At baseline medication was assessed 1 time (anamnesis)]

    17. Digitalis [1-time: At baseline medication was assessed 1 time (anamnesis)]

    18. Aldosterone Antagonists [1-time: At baseline medication was assessed 1 time (anamnesis)]

    19. Male Gender as Predictor for SDB in Chronic HF [1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)]

      From the total number of participants, the number of male patients without and with SDB were counted and an odds Ratio for male sex as predictor for SDB in chronic heart failure

    20. Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF [1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)]

      From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for AF as predictor for SDB in chronic heart failure

    21. Ischemic Etiology as Predictor for SDB in Chronic HF [1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)]

      From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for ischemic etiology as predictor for SDB in chronic heart failure

    22. NYHA Class >= III as Predictor for SDB in Chronic HF [1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)]

      From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for NYHA (New York Heart Association - class I not impaired, class II slighly impaired, class III severly impaired, class IV = unable to perform normal tasks) class≥III as predictor for SDB in chronic heart failure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must be over 18

    • Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines

    • Left ventricular systolic dysfunction (LVEF ≤ 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks

    • NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months

    • Patient is able to fully understand study information and signed informed consent

    Exclusion Criteria:

    • Life expectancy < 1 year for diseases unrelated to chronic HF

    • Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months

    • CRT-implantation (either CRT-D or CRT-P) scheduled or within 6 months

    • Transient ischemic attack (TIA) or Stroke within 3 months

    • Hemodynamically significant uncorrected primary valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery

    • Acute myocarditis/pericarditis within 6 months

    • Current CPAP or bilevel therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Westmead Hospital Westmead New South Wales Australia 2145
    2 Rivercity Private Hospital Auchenflower Queensland Australia 4066
    3 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    4 Melbourne Sleep Disorders Centre East Melbourne Victoria Australia 3002
    5 Baker IDI Heart and Diabetes Institute Melbourne Victoria Australia 3004
    6 St Vincents and Mercy Private Hospital Melbourne Victoria Australia 3065
    7 Hollywood Private Hospital (CVS) Nedlands Western Australia Australia 6009
    8 Cardiopraxis Ingelheim Ingelheim am Rhein Rheinland-Pfalz Germany 55218
    9 Praxis Dr. Frieske Aachen Germany 52062
    10 Universitätsklinikum Aachen Aachen Germany 52074
    11 DRK Krankenhaus Alzey Germany 55232
    12 Gemeinschaftspraxis Weiß/ Dr. Heesing Arnsberg Germany 59821
    13 Zentralklinikum Bad Berka Bad Berka Germany 99437
    14 Herzzentrum Bad Krozingen Bad Krozingen Germany 79189
    15 Klinik Lazariterhof Bad Krozingen Germany 79189
    16 Praxis Dr. Bauer Bad Mergentheim Germany 97980
    17 HDZ NRW Bad Oeynhausen Germany 32545
    18 Kardiologische Praxis Dr. Stroh Bad Wurzach Germany 88410
    19 Oberlausitz-Kliniken gGmbH Bautzen Germany 02625
    20 Kardiopraxis Rheinberg Bergisch Gladbach Germany 51465
    21 Charité Campus Mitte CCM Berlin Germany 10117
    22 Charité Campus Mitte Berlin Germany 10117
    23 Praxis Gemeinschaft Frille Berlin Germany 10178
    24 POLIKUM Friedenau Berlin Germany 12157
    25 Gemeinschaftspraxis Groß-Ziethener Chaussee Berlin Germany 12355
    26 Unfallkrankenhaus Berlin Berlin Germany 12683
    27 Jüdisches Krankenhaus Berlin Berlin Germany 13347
    28 Charité Campus Virchow Klinikum Berlin Germany 13353
    29 Charité Campus Virchow-Klinikum Berlin Germany 13353
    30 Praxis Westend Berlin Germany 14050
    31 Herzzentrum Brandenburg Bernau Germany 16321
    32 Praxis für Lunge,Herz und Schlaf Bielefeld Germany 33617
    33 Kardiologie Gemeinschaftspraxis Dr. Tenholt Bochum Germany 44787
    34 Universitätsklinikum Bergmannsheil Bochum Germany 44789
    35 Augusta Krankenanstalten Bochum Bochum Germany 44791
    36 St.-Josephs-Hospital Bochum Germany 44791
    37 Kardiologie Kemnade Bochum Germany 44797
    38 Kardiologische Praxis Dr. Staubach Bochum Germany 44866
    39 Praxis für Kardiologie Bonn Bonn Germany 53127
    40 Universitätsklinikum Bonn Bonn Germany 53127
    41 Kardiologische Praxis Marschner Bonn Germany 53225
    42 Gemeinschaftspraxis Kardiologie Bottrop Germany 46236
    43 Gemeinschaftspraxis Dres. Tinnefeld Bottrop Germany 46240
    44 Kardiologie Bühl Brühl Germany 50321
    45 Mediclin Rehazentrum Spreewald Burg/Spreewald Germany 03096
    46 Gemeinschaftspraxis Kardiologie Dr. Becker Castrop-Rauxel Germany 44575
    47 Kardiologische Praxis Dr. Isbruch Castrop-Rauxel Germany 44577
    48 MVZ am Küchwald Chemnitz Germany 09113
    49 Klinikum Coburg GmbH Coburg Germany 96450
    50 Fachkrankenhaus Coswig Coswig Germany 01640
    51 Carl-Thiem-Klinikum gGmbH Cottbus Germany 03042
    52 Praxis Dr. Hecker Dortmund Germany 44135
    53 Kardiologie - Gemeinschaftspraxis Dortmund Dortmund Germany 44137
    54 Kardiologie-Gemeinschaftspraxis Dortmund Dortmund Germany 44137
    55 Kardiologische Praxis Dr. Golling Dortmund Germany 44137
    56 Klinikum Dortmund gGmbH Dortmund Germany 44137
    57 Clinical Trial Site Services Dortmund Germany 44141
    58 Kardiologische Praxis Dr. Wetzel Dortmund Germany 44141
    59 Kardiologische Praxis Dr. Lodde Dortmund Germany 44147
    60 Kardiologische Praxis Dr. Dröse Dortmund Germany 44263
    61 Facharztzentrum Dresden-Neustadt GbR Dresden Germany 01099
    62 Gemeinschaftpraxis Dres. Schmidt/Gronke Dresden Germany 01219
    63 Praxis Dr. Hohensee Dresden Germany 01277
    64 Herzzentrum Universität Dresden Dresden Germany 01307
    65 Khs Florence-Nightingale Duesseldorf Germany 40489
    66 goMedus Gesundheitszentrum Düsseldorf Germany 40212
    67 Kardiologische Praxis Dr. Horowitz Düsseldorf Germany 40215
    68 Kardiologische Praxis Dr. Raff Düsseldorf Germany 40237
    69 Florence-Nightingale Krankenhaus Düsseldorf Germany 40489
    70 Kardiologie Oberkassel Düsseldorf Germany 40545
    71 Gemeinschaftspraxis PD Dr. Lankisch Düsseldorf Germany 40597
    72 Fachärzte für Innere Medizin Dres Ritter, Richter, Mehrer, Kahl Emmendingen Germany 79312
    73 Helios Klinikum Erfurt-Kardiologie Erfurt Germany 99089
    74 Helios Klinikum Erfurt-Schlafmedizin Erfurt Germany 99089
    75 Universitätsklinikum Erlangen Erlangen Germany 91054
    76 Westdeutsches Herzzentrum, Universitätsklinikum Essen Essen Germany 45122
    77 Kardiologische Praxis Dr. Cord Müller Essen Germany 45131
    78 Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch Essen Germany 45131
    79 Kardiologische Praxis Prof. Winter Essen Germany 45134
    80 Kardiologie Praxis Dr. Bonnekamp Essen Germany 45136
    81 Praxis Dr. Tekiyeh Essen Germany 45136
    82 Elisabeth-Krankenhaus Essen Essen Germany 45138
    83 Ruhrlandklinik Essen Essen Germany 45239
    84 Praxis Dr. Rau Essen Germany 45276
    85 Kath. Kliniken Essen / Philippusstift Essen Germany 45359
    86 Gemeinschaftspraxis Dres. Guckenbiehl Flonheim Germany 55237
    87 Kardiologische Praxis Dr. Kruse Forst Germany 03149
    88 CardioVasculäres Centrum Frankfurt Frankfurt Germany 60389
    89 Praxis Dr. Diedrichs Frechen Germany 50226
    90 Universitaetsklinikum Freiburg Freiburg im Breisgau Germany 79106
    91 Universitätsklinikum Freiburg Freiburg im Breisgau Germany 79106
    92 Gemeinschaftspraxis Dres. Böhmeke/Schmidt Gladbeck Germany 45964
    93 Kardiologische Praxis Dr. Hug Günzburg Germany 89312
    94 Kardiologische Praxis Gütersloh Gütersloh Germany 33330
    95 Gemeinschaftspraxis Dres Leischik/Littwitz Hagen Germany 58095
    96 Kardiologische Praxis Dr. Arens Hagen Germany 58095
    97 Gemeinschaftspraxis Dres. Subin/Lutter Hamburg Germany 20095
    98 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany 20246
    99 Asklepios Klinik Barmbek Hamburg Germany 22291
    100 Internistenpraxis Alstertal Hamburg Hamburg Germany 22399
    101 Kardiologische Praxis Dr. Schröder Hamburg Germany 22765
    102 Kardiologische Praxis Dr. Cierpka Hannover Germany 30159
    103 Praxis Dr. Hötte Hannover Germany 30449
    104 Siloah Krankenhaus Hannover Germany 30449
    105 Kardiologische Praxis Dr. Hartung Hannover Germany 30559
    106 Heidelberger Praxisklinik für Kardiologie Heidelberg Germany 69115
    107 Praxis Dr. Durak Heidelberg Germany 69115
    108 Universitätsklinikum Heidelberg Heidelberg Germany 69120
    109 Thoraxklinik Heidelberg gGmbH Heidelberg Germany 69126
    110 Evangelisches Krankenhaus Herne Herne Germany 44623
    111 EvK Herne Herne Germany 44623
    112 Kardiologische Praxis Dr. Furche Herne Germany 44623
    113 Gemeinschaftspraxis Dr. Bruch Herne Germany 44629
    114 Kardiologische Praxis Dr. Schlichting Herne Germany 44649
    115 St. Elisabeth-Hospital Herten gGmbH Herten Germany 45699
    116 Praxis für Innere Medizin/Kardiologie Hoyerswerda Germany 02977
    117 Gemeinschaftspraxis Dres. Dobler/Turin Karlstadt Germany 97753
    118 Ambulantes Herzzentrum Kassel Kassel Germany 34121
    119 Kardiologische Praxis Dr. Siegfried Frickel Kempen Germany 47906
    120 Klinik Kitzinger Land Kitzingen Germany 97318
    121 Praxis Dr. Krater Krefeld Germany 47799
    122 Helios Klinikum Krefeld Krefeld Germany 47805
    123 St.-Vinzenz Hospital Köln Germany 50733
    124 Kardiologische Praxis Dr. Fritsch Köln Germany 50737
    125 Malteser Krankenhaus St. Hildegardis Köln Germany 50931
    126 Klinikum der Universität zu Köln- Herzzentrum Köln Germany 50937
    127 Prof. Franzen Institut Köln Germany 50937
    128 Universitätsklinikum Köln-Herzzentrum Köln Germany 50937
    129 Praxis Dr. Anselm Bäumer Köln Germany 51065
    130 Gemeinschaftspraxis Dres. Gysan/Heinzler/May Köln Germany 51105
    131 Klinikum Dahme-Spreewald GmbH Königs Wusterhausen Germany 15711
    132 Universitätsklinikum Leipzig-Herzzentrum Leipzig Germany 04289
    133 Helios Krankenhaus Leisnig Leisnig Germany 04703
    134 Gemeinschaftspraxis Dr. Hilgedieck/Sava Lengerich Germany 49525
    135 Kardiologische Praxis Dr. Faber Lindlar Germany 51784
    136 Ärztezentrum Holthausen-Biene Lingen Germany 49808
    137 Kardiologische Praxis Ludwigsburg Ludwigsburg Germany 71634
    138 Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie Lübeck Germany 23538
    139 Klinikum der Johannes Gutenberg-Universität Mainz Mainz Germany 55101
    140 Gemeinschaftspraxis Dres. Heifer/Loster/Schernus Mannheim Germany 68161
    141 Gemeinschaftspraxis für Herz & Gefäße Mannheim Germany 68161
    142 Universitätsklinik Mannheim-Kardiologie Mannheim Germany 68167
    143 Gemeinschaftspraxis Dres. Brandt / Jakobs Mannheim Germany 68305
    144 Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie Marburg Germany 35043
    145 Praxis Dr. Schnabel Meissen Germany 01662
    146 Gemeinschaftspraxis Dr. Jocham Memmingen Germany 87700
    147 Praxis für Kardiologie Dr. med. Menz Menden Germany 58706
    148 Herz-& Gefäßpraxis Metzingen Germany 72555
    149 Praxis Kutenhausen Minden Germany 32425
    150 Krankenhaus Bethanien Moers Germany 47441
    151 Kardiologische Praxis Dr. Schön Mühldorf Germany 84453
    152 Evangelisches Krankenhaus Mülheim Mülheim an der Ruhr Germany 45468
    153 Kardiologie am Rotkreuzplatz München Germany 80634
    154 Gemeinschaftspraxis Dres. Wauer / Windstetter München Germany 80799
    155 Kardiologische Praxis Dr. Herholz München Germany 80809
    156 Klinikum Augustinum München München Germany 81375
    157 Praxis Dres. Böhme/Linke München Germany 81667
    158 Kardiologische Praxis Dr. Muradi Münster Germany 29633
    159 Universitätsklinikum Münster Münster Germany 48149
    160 Praxis für Kardiologie Dr. med. Hewing Münster Germany 48151
    161 Städtisches Khs Lukas Neuss Germany 41472
    162 Kardiologische Praxis Nienburg Nienburg Germany 31582
    163 Klinikum Nürnberg Süd Nürnberg Germany 90471
    164 Kardiologische Praxis Dr. Gumbrecht Ochtrup Germany 48607
    165 Kardiologische Praxis Dr. Hassler Plauen Germany 8523
    166 Kardiologische Praxis Dr. Wiethölter Radebeul Germany 01445
    167 Praxis für Kardiologie Ratingen Ratingen Germany 40878
    168 Praxis Dr. Fröhlich Ratingen Germany 40885
    169 DRK Krankenhaus Mölln-Ratzeburg Ratzeburg Germany 23909
    170 Ambulantes Cardiovaskuläres Centrum Ravensburg Germany 88212
    171 Gemeinschaftspraxis Dr. Weber/Dr. Feja Recklinghausen Germany 45657
    172 Universitätsklinikum Regensburg Regensburg Germany 93053
    173 Khs St. Adolf Stift Reinbek Germany 21465
    174 Praxis Dr. Hein Reinbek Germany 21465
    175 Kardiologische Praxis Dr. Kleinz Remscheid Germany 42853
    176 Praxis Dr. Nebel Rheine Germany 48429
    177 Praxis Dr. Kestermann Rheine Germany 48431
    178 Kardiologische Praxis Dr. Figura Rinteln Germany 31737
    179 Kardiologische Praxis Dr. Heinze Schwerte Germany 58239
    180 Praxis Dr. Ebeling Schönefeld Germany 12529
    181 Praxisgemeinschaft Cardio-Soest Soest Germany 59494
    182 Facharztzentrum Sonneberg Sonneberg Germany 96515
    183 Kreiskrankenhaus Stollberg GmbH Stollberg Germany 09366
    184 Kardiologische Praxis Dr. Birkenhagen Stollberg Germany 9366
    185 Klinikum Uelzen GmbH Uelzen Germany 29525
    186 Herzklinik Ulm Dr. Haerer und Partner Ulm Germany 89077
    187 Zentrum für Innere Medizin Uni Ulm Ulm Germany 89081
    188 Katharinen Hospital Unna Unna Germany 59423
    189 Kardiologische Praxis Dr. Burkhard-Meier Viersen Germany 41747
    190 Praxis Dr. Gerritsen Waldkraiburg Germany 84478
    191 Fachkliniken Wangen Wangen Germany 88239
    192 Stiftungsklinik Weißenhorn Weißenhorn Germany 89264
    193 Kardiologisch angiologische Gemeinschaftspraxis Wiesbaden Germany 65183
    194 Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck Wiesbaden Germany 65183
    195 Kardiologische Praxis Dr. Vrettos Witten Germany 58452
    196 Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt Worms Germany 67547
    197 Comprehensive Heart Failure Center, Universitätsklinikum Würzburg Würzburg Germany 97080
    198 Universitätsklinikum Würzburg Würzburg Germany 97080
    199 Evangel. Khs Zweibrücken Zweibrücken Germany 66482

    Sponsors and Collaborators

    • ResMed

    Investigators

    • Principal Investigator: Erland Erdmann, Prof, Klinikum der Universität zu Köln
    • Principal Investigator: Helmut Teschler, Prof, Ruhrlandklinik Essen
    • Study Director: Holger Woehrle, MD, ResMed

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ResMed
    ClinicalTrials.gov Identifier:
    NCT01500759
    Other Study ID Numbers:
    • 001
    First Posted:
    Dec 28, 2011
    Last Update Posted:
    Jul 9, 2020
    Last Verified:
    May 1, 2020
    Keywords provided by ResMed
    chronic heart failure
    heart failure
    hf
    sleep-disordered breathing
    sdb
    nyha
    lvef
    cheyne stokes
    central sleep apnoea
    sleep apnoea
    Additional relevant MeSH terms:
    Respiratory Aspiration
    Sleep Apnea Syndromes
    Heart Failure
    Systolic Murmurs

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Period Title: Overall Study
    STARTED 3686 3190
    COMPLETED 3686 3190
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB Total
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Total of all reporting groups
    Overall Participants 3686 3190 6876
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65
    (12)
    69
    (11)
    67
    (11.5)
    Sex: Female, Male (Count of Participants)
    Female
    932
    25.3%
    516
    16.2%
    1448
    21.1%
    Male
    2754
    74.7%
    2674
    83.8%
    5428
    78.9%

    Outcome Measures

    1. Primary Outcome
    Title Prevalence of SDB in Chronic HF Patients
    Description SDB= Sleep disordered breathing; HF= Heart failure
    Time Frame 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 6876
    Count of Participants [Participants]
    3190
    86.5%
    2. Secondary Outcome
    Title Left Ventricular Ejection Fraction
    Description Amount of blood in the left ventricle at the end of Diastole that is being pumped into the System during systole
    Time Frame 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Mean (Standard Deviation) [% ejection fraction]
    33.6
    (8.0)
    32.8
    (8.3)
    3. Secondary Outcome
    Title Age
    Description Age years
    Time Frame 1-time single assessment at baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Mean (Standard Deviation) [years]
    65
    (12)
    69
    (11)
    4. Secondary Outcome
    Title Body Mass Index
    Description
    Time Frame 1-time single assessment at baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Mean (Standard Deviation) [kg/m˄2]
    28.1
    (5.0)
    28.9
    (5.2)
    5. Secondary Outcome
    Title Male Gender
    Description
    Time Frame 1-time single assessment at baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Count of Participants [Participants]
    2754
    74.7%
    2674
    83.8%
    6. Secondary Outcome
    Title NYHA Class ≥III
    Description New York Heart Association Class III: Marked Limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in undue breathlessness, fatigue or palpitations.
    Time Frame At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Count of Participants [Participants]
    2566
    69.6%
    2341
    73.4%
    7. Secondary Outcome
    Title Ischemic Etiology
    Description Ischemic etiology describes a condition where a weakening or disease of the heart muscle is caused by reduced supply of blood (underlying cause might be the coronary artery). Secondary outcome ischemic etiology describes the cause of heart failure (HF) "ischemic" in HF patients without and with sleep-disordered breathing in percent of the respective study arm/group: e.g. x% of patients without SDB have HF with an ischemic etiology.
    Time Frame 1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Count of Participants [Participants]
    1961
    53.2%
    1742
    54.6%
    8. Secondary Outcome
    Title Atrial Fibrillation
    Description
    Time Frame 1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Count of Participants [Participants]
    863
    23.4%
    1001
    31.4%
    9. Secondary Outcome
    Title Nocturnal Dyspnea
    Description
    Time Frame 1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Count of Participants [Participants]
    672
    18.2%
    800
    25.1%
    10. Secondary Outcome
    Title Nocturia ≥3 Times/Night
    Description
    Time Frame 1-time: At baseline nocturia was assessed 1 time (anamnesis)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Count of Participants [Participants]
    580
    15.7%
    660
    20.7%
    11. Secondary Outcome
    Title Apnoea-Hypopnea-Index
    Description Number of Apnoeas (cessation of airflow for at least 10 seconds) and hypopneas (reduced airflow for at least 10 seconds) per hours of sleep
    Time Frame 1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Mean (Standard Deviation) [events/hour]
    6
    (4)
    31
    (14)
    12. Secondary Outcome
    Title Oxygen Desaturation Index
    Description Number of times that arterial blood oxygen saturation Drops by ≥3% from the Basic value.
    Time Frame 1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Mean (Standard Deviation) [events/hour]
    8
    (10)
    24
    (15)
    13. Secondary Outcome
    Title Mean SpO2
    Description Saturation of oxygen
    Time Frame 1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Mean (Standard Deviation) [%oxygen saturation]
    93
    (2)
    92
    (3)
    14. Secondary Outcome
    Title Min SpO2
    Description Lowest Saturation with oxygen
    Time Frame 1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Mean (Standard Deviation) [% oxygen saturation]
    83
    (6)
    80
    (6)
    15. Secondary Outcome
    Title Medication ACE Inhibitors and/ARBs
    Description ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker
    Time Frame 1-time: At baseline medication was assessed 1 time (anamnesis)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Count of Participants [Participants]
    3269
    88.7%
    2812
    88.2%
    16. Secondary Outcome
    Title Beta-blocker
    Description
    Time Frame 1-time: At baseline medication was assessed 1 time (anamnesis)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Count of Participants [Participants]
    3284
    89.1%
    2824
    88.5%
    17. Secondary Outcome
    Title Diuretics
    Description
    Time Frame 1-time: At baseline medication was assessed 1 time (anamnesis)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Count of Participants [Participants]
    2805
    76.1%
    2617
    82%
    18. Secondary Outcome
    Title Digitalis
    Description
    Time Frame 1-time: At baseline medication was assessed 1 time (anamnesis)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Count of Participants [Participants]
    717
    19.5%
    599
    18.8%
    19. Secondary Outcome
    Title Aldosterone Antagonists
    Description
    Time Frame 1-time: At baseline medication was assessed 1 time (anamnesis)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    Measure Participants 3686 3190
    Count of Participants [Participants]
    1808
    49.1%
    1454
    45.6%
    20. Secondary Outcome
    Title Male Gender as Predictor for SDB in Chronic HF
    Description From the total number of participants, the number of male patients without and with SDB were counted and an odds Ratio for male sex as predictor for SDB in chronic heart failure
    Time Frame 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Patients With Chronic HF Without SDB Male Patients With Chronic Heart Failure and SDB Male
    Arm/Group Description patients with chronic heart failure and no sleep disordered breathing who are male patients with chronic heart failure and sleep disorderd breathing who are male
    Measure Participants 3686 3190
    Count of Participants [Participants]
    2754
    74.7%
    2674
    83.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Chronic HF With SDB, Chronic HF With SDB
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.90
    Confidence Interval (2-Sided) 95%
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    21. Secondary Outcome
    Title Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF
    Description From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for AF as predictor for SDB in chronic heart failure
    Time Frame 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Patients With Chronic HF Without SDB and AF Patients With Chronic Heart Failure and SDB and AF
    Arm/Group Description patients with chronic heart failure and no sleep disordered breathing who have atrial fibrillation (AF) patients with chronic heart failure and sleep disorderd breathing who have atrial fibrillation (AF)
    Measure Participants 3686 3190
    Count of Participants [Participants]
    863
    23.4%
    1001
    31.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Chronic HF With SDB, Chronic HF With SDB
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.19
    Confidence Interval (2-Sided) 95%
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    22. Secondary Outcome
    Title Ischemic Etiology as Predictor for SDB in Chronic HF
    Description From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for ischemic etiology as predictor for SDB in chronic heart failure
    Time Frame 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Patients With Chronic HF Without SDB and Ischemic Etiology Patients With Chronic Heart Failure and SDB and Ischemic Etiol
    Arm/Group Description patients with chronic heart failure and no sleep disordered breathing who have an ischemic etiology (reduced blood flow to the heart muscle) of HF patients with chronic heart failure and sleep disorderd breathing who have an ischemic etiology (reduced blood flow to the heart muscle) of HF
    Measure Participants 3686 3190
    Count of Participants [Participants]
    1961
    53.2%
    1742
    54.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Chronic HF With SDB, Chronic HF With SDB
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.92
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    23. Secondary Outcome
    Title NYHA Class >= III as Predictor for SDB in Chronic HF
    Description From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for NYHA (New York Heart Association - class I not impaired, class II slighly impaired, class III severly impaired, class IV = unable to perform normal tasks) class≥III as predictor for SDB in chronic heart failure
    Time Frame 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Patients With Chronic HF Without SDB and NYHA>III Patients With Chronic Heart Failure and SDB and NYHA >III
    Arm/Group Description patients with chronic heart failure and no sleep disordered breathing who are classified as NYHA >=III patients with chronic heart failure and sleep disorderd breathing who are classified as NYHA >=III
    Measure Participants 3686 3190
    Count of Participants [Participants]
    2566
    69.6%
    2341
    73.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Chronic HF With SDB, Chronic HF With SDB
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.12
    Confidence Interval (2-Sided) 95%
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Non-serious adverse events were not collected in this observational study. Usual side-effects of therapy in clinical routine are well described. Serious adverse events (SAE) were recorded, but in this observational study only those in connection to the device: Unexpected serious device defects (USADE). No device effects were recorded during the course of this study.
    Arm/Group Title Chronic HF Without SDB Chronic HF With SDB
    Arm/Group Description Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15) Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
    All Cause Mortality
    Chronic HF Without SDB Chronic HF With SDB
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Chronic HF Without SDB Chronic HF With SDB
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3686 (0%) 0/3190 (0%)
    Other (Not Including Serious) Adverse Events
    Chronic HF Without SDB Chronic HF With SDB
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Medical Affairs CRS
    Organization ResMed Germany Inc
    Phone 089990100
    Email ClinicalResearch&Strategy@ResMed.com
    Responsible Party:
    ResMed
    ClinicalTrials.gov Identifier:
    NCT01500759
    Other Study ID Numbers:
    • 001
    First Posted:
    Dec 28, 2011
    Last Update Posted:
    Jul 9, 2020
    Last Verified:
    May 1, 2020