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MS: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

Sponsor
ResMed (Industry)
Overall Status
Completed
CT.gov ID
NCT01164592
Collaborator
(none)
312
Enrollment
94
Locations
2
Arms
34
Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF study.

Condition or Disease Intervention/Treatment Phase
  • Device: adaptive servoventilation (ASV)
 Phase 4

Detailed Description

This substudy is performed within the SERVE-HF Study, a randomised, multi-centre,international trial with parallel group design, with patients randomised to either control (optimal medical management) or active treatment (optimal medical treatment plus use of adaptive servoventilation) in a 1:1 ratio. The randomization will be the same as in the parent study. For this purpose, the randomization of the parent study will be stratified as to whether a patient is included in the substudy or not. 300 patients will be recruited for the substudy overall.

For the purpose of this substudy, patients will be followed up for a period of 12 months.

The following extra tests will be performed at the baseline visit, the 3 months follow up and the 12 months follow up:

  • Echocardiogram (for both groups)

  • cMRI (for both groups)

  • PSG (at the baseline visit only for patients in the treatment group and at 3 months follow up and the 12 months follow up for all patients)

  • 4 questionnaires (for both groups)

  • Additional blood testing (for both groups)

Study Design

Study Type:
Interventional
Actual Enrollment :
312 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
SERVE-HF: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Therapy with adaptive servo ventilation

optimal medical therapy + adaptive servoventilation

Device: adaptive servoventilation (ASV)
Patients randomised to therapygroup should use the adaptive servoventilation (ASV) device each night at least 3 hours
Other Names:
  • Adaptive Servo-Ventilation with AutoSet CS

    		•
    No Intervention: Optimal medical therapy according to guidelines

    optimal medical therapy

    Outcome Measures

    Primary Outcome Measures

    1. Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 12 months of therapy as measured by echocardiography (Echo). [Baseline (Randomization), 6- and 12 month-Follow-up-visit]

    Secondary Outcome Measures

    1. Changes in left and right ventricular function [Baseline (Randomization), 6-and 12-month-Follow-up visit]

    2. Changes in LV systolic and diastolic indexed volumes [Baseline (Randomization), 6- and 12-month-Follow-up-visit]

    3. Changes in right ventricular (RV) systolic and diastolic indexed volumes [Baseline (Randomization), 6- and 12-month-Follow-up-visit]

    4. Changes in LV and RV mass [Baseline (Randomization), 6- and 12-month-Follow-up-visit]

    5. Changes in LV sphericity index and LV end-systolic global wall stress [Baseline (Randomization), 6- and 12-month-Follow-up-visit]

    6. Changes in sleep duration and sleep stages as well as arousals [Baseline (Randomization), 6- and 12-month-Follow-up-visit]

    7. Changes in sleep-disordered breathing [Baseline (Randomization), 6- and 12-month-Follow-up-visit]

    8. Changes in quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) [Baseline (Randomization), 6- and 12-month-Follow-up-visit]

    9. Changes in mental status assessed by Mini-Mental State Examination (MMSE) [Baseline (Randomization), 6- and 12-month-Follow-up-visit]

    10. Changes in Patient Health Questionnaire-9 (PHQ-9) score and Patient Anxiety Questionnaire GAD-7 [Baseline (Randomization), 6- and 12-month-Follow-up-visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    The inclusion and exclusion criteria are mainly those applicable for the parent study; SERVE-HF. The inclusion and exclusion criteria are listed here.

    INCLUSION CRITERIA FOR SERVE-HF STUDY:

    • Over 22 years of age

    • Severe Chronic Heart Failure (CHF) with NYHA class III-IV or NYHA class II with at least one hospitalisation for HF within the last 24 months

    • Left ventricular ejection fraction (LVEF) less than or equal to 45% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented less than 12 weeks before randomisation

    • Diagnosis of sleep disordered breathing (SDB) with an apnoea-hypopnoea-index (AHI) of

    15/hr with at least 50% central events and a central AHI of at least 10/hr

    • Clinically stable with no change in medication and no unplanned hospitalisation for heart failure in preceding month

    • Optimised medical treatment according to the applicable guidelines

    • Able to provide informed consent

    ADDITIONAL INCLUSION CRITERIA FOR THE SUBSTUDY

    • Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with ≥ 50% central events and a central AHI ≥10/hour, derived from full polysomnography (based on total sleep time), documented less than 4 weeks before randomization. Flow measurements have to be performed with nasal cannula

    EXCLUSION CRITERIA FOR THE SERVE-HF STUDY:

    • Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1)<50% predicted

    • Oxygen saturation at rest during the day 90% at the time of inclusion

    • Current use of Positive Airway Pressure (PAP) therapy

    • Life expectancy < 1 year for diseases unrelated to chronic heart failure

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

    • Implantation of ICD (implanted cardiodefibrillator) or CRT (cardiac resynchronisation therapy) scheduled or within 6 months prior to randomisation

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

    • Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial

    • Acute myocarditis/pericarditis within 6 months prior to randomisation

    • Untreated or therapy refractory Restless legs Syndrome (RLS)

    • Pregnancy

    ADDITIONAL EXCLUSION CRITERIA FOR THE SUBSTUDY

    • Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas

    • Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomisation

    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 St. Vincents and Mercy Private Hospital Melbourne Victoria Australia 3065
    6 Hollywood Private Hospital (CVS) Nedlands Western Australia Australia 6009
    7 St. Anne's University Hospital Brno Czech Republic 65691
    8 Helsinki University Hospital Helsinki Finland 00290
    9 Unesta Research Centre Tampere Finland 33520
    10 Tampere University Hospital, Pirkanmaa sairaanhoitopiiri Tampere Finland 33521
    11 Clinique Mutualiste des Eaux Claires Grenoble France 38000
    12 CHU Grenoble, Hopital Michallon Grenoble France 38043
    13 CHU de Poitiers Poitiers France 86000
    14 Universitätsklinikum Aachen Aachen Germany 52074
    15 DRK Krankenhaus Alzey Germany 55232
    16 Herzzentrum Bad Krozingen Bad Krozingen Germany 79189
    17 Herz- und Diabeteszentrum NRW Bad Oeynhausen Germany 32545
    18 Charité Campus Mitte CCM Berlin Germany 10117
    19 Charité Campus Mitte Berlin Germany 10117
    20 POLIKUM Friedenau Berlin Germany 12157
    21 Unfallkrankenhaus Berlin Berlin Germany 12683
    22 Jüdisches Krankenhaus Berlin Berlin Germany 13347
    23 Praxis für Lunge Herz und Schlaf Bielefeld Germany 33617
    24 Kardiologische Praxis Marschner Bonn Germany 53225
    25 Helios Klinikum Borna Borna Germany 04552
    26 Kardiologie Brühl Brühl Germany 50321
    27 Gemeinschaftspraxis Kardiologie Dr. Becker Castrop-Rauxel Germany 44575
    28 Kardiologische Praxis Dr. Isbruch Castrop-Rauxel Germany 44577
    29 Praxis Dr. Hecker Dortmund Germany 44135
    30 Kardiologische Praxis Dr. Wetzel Dortmund Germany 44141
    31 Praxis Dr. Lodde Dortmund Germany 44147
    32 Facharztzentrum Dresden-Neustadt GbR Dresden Germany 01099
    33 Gemeinschaftpraxis Dres. Schmidt/Gronke Dresden Germany 01219
    34 Praxis Dr. Hohensee Dresden Germany 01277
    35 Herzzentrum Universität Dresden Dresden Germany 01307
    36 Khs Florence-Nightingale Duesseldorf Germany 40489
    37 Kardiologie Oberkassel Düsseldorf Germany 40545
    38 Gemeinschaftspraxis PD Dr. Lankisch Düsseldorf Germany 40597
    39 Universitätsklinikum Essen Essen Germany 45122
    40 Kardiologie Praxis Dr. Bonnekamp Essen Germany 45136
    41 Praxis Dr. Tekiyeh Essen Germany 45136
    42 Ruhrlandklinik Essen Essen Germany 45239
    43 Kath. Kliniken Essen/ Philippusstift Essen Germany 45359
    44 Gemeinschaftspraxis Dres. Guckenbiehl Flonheim Germany 55237
    45 CardioVaskuläres Centrum Frankfurt Frankfurt Germany 60389
    46 Praxis Dr. Diedrichs Frechen Germany 50226
    47 Universitätsklinikum Freiburg Freiburg im Breisgau Germany 79106
    48 Kardiologische Praxis Gütersloh Gütersloh Germany 33330
    49 Gemeinschaftspraxis Dres Leischik/Littwitz Hagen Germany 58095
    50 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany 20246
    51 Asklepios Klinik Barmbek Hamburg Germany 22291
    52 Universitätsklinikum Heidelberg Heidelberg Germany 69120
    53 Thoraxklinik Heidelberg gGmbH Heidelberg Germany 69126
    54 Lungenklinik Hemer Hemer Germany 58675
    55 B&B GmbH Herne Germany 44623
    56 Cardio-Praxis Herne Dr. Furche Herne Germany 44623
    57 Gemeinschaftspraxis Dr. Bruch Herne Germany 44629
    58 Kardiologische Praxis Dr. Schlichting Herne Germany 44649
    59 Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet Herne Germany 44651
    60 St. Elisabeth-Hospital Herten gGmbH Herten Germany 45699
    61 Lungenfachklinik Immenhausen Immenhausen Germany 34376
    62 Cardiopraxis Ingelheim Ingelheim Germany 55218
    63 Gemeinschaftspraxis Dres. Dobler/Turin Karlstadt Germany 97753
    64 Malteser Krankenhaus St. Hildegardis Köln Germany 50931
    65 Klinikum der Universität zu Köln- Herzzentrum Köln Germany 50937
    66 Klinikum der Universität zu Köln-Schlaflabor Köln Germany 50937
    67 Praxis Dr. Anselm Bäumer Köln Germany 51065
    68 Gemeinschaftspraxis Dres. Gysan/Heinzler/May Köln Germany 51105
    69 Universität Leipzig -Herzzentrum Leipzig Germany 04289
    70 Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie Lübeck Germany 23538
    71 Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor Lübeck Germany 23538
    72 Praxis für Kardiologie Dr. med. Menz Menden Germany 58706
    73 Krankenhaus Bethanien Moers Germany 47441
    74 Kardiologische Praxis Dr. Schön Mühldorf Germany 84453
    75 Evangelisches Krankenhaus Mülheim Mülheim an der Ruhr Germany 45468
    76 Lungenärzte am Rotkreuzplatz München Germany 80634
    77 Klinikum Augustinum München München Germany 81375
    78 Universitätsklinikum Münster Münster Germany 48149
    79 Städtisches Khs Lukas Neuss Germany 41472
    80 Kardiologische Praxis Nienburg Nienburg Germany 31582
    81 Praxis Dr. Fröhlich Ratingen Germany 40885
    82 Universitätsklinikum Regensburg Regensburg Germany 93053
    83 Khs St. Adolf Stift Reinbek Germany 21465
    84 Praxis Dr. Hein Reinbek Germany 21465
    85 Katharinen Hospital Unna Unna Germany 59423
    86 Praxis Dr. Gerritsen Waldkraiburg Germany 84478
    87 Kardiologisch angiologische Gemeinschaftspraxis Wiesbaden Germany 65183
    88 Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck Wiesbaden Germany 65183
    89 Missionsärztliche Klinik Würzburg Wuerzburg Germany 97074
    90 Comprehensive Heart Failure Center, Universitätsklinikum Würzburg Würzburg Germany 97080
    91 University Medical Center Groningen Groningen Netherlands 9700 RB
    92 Cardiocentro Ticino Lugano Switzerland 6900
    93 Ospedale Regionale di Lugano Lugano Switzerland 6903
    94 Brompton Hospital London United Kingdom UK-SW36NP

    Sponsors and Collaborators

    • ResMed

    Investigators

    • Principal Investigator: Martin Cowie, Prof, Royal Brompton Hospital, London
    • Study Director: Holger Woehrle, MD, ResMed

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ResMed
    ClinicalTrials.gov Identifier:
    NCT01164592
    Other Study ID Numbers:
    • 01a
    First Posted:
    Jul 16, 2010
    Last Update Posted:
    Aug 7, 2015
    Last Verified:
    Aug 1, 2015
    Keywords provided by ResMed
    Heart failure (HF)
    Sleep disordered breathing (SDB)
    Cheyne Stokes Respiration (CSR)
    Adaptive Servoventilation (ASV)
    Additional relevant MeSH terms:
    Cheyne-Stokes Respiration
    Sleep Wake Disorders
    Heart Failure

    Study Results

    No Results Posted as of Aug 7, 2015