ADVENT-HF: Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure
Study Details
Study Description
Brief Summary
Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. This study is looking at whether a respiratory device known as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations and death in subjects with HF and SA. Study subjects will randomly receive either their regular medications OR their regular medications plus ASV. They will be followed for approximately 5 years and information relevant to their health will be collected and compared.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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No Intervention: Standard HF therapy Subjects will receive optimal standard therapy for heart failure conforming to national guidelines as determined by the referring cardiologist |
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Active Comparator: Standard therapy for HF + ASV Subjects will receive treatment with Adaptive Servo Ventilation in addition to optimal standard therapy for heart failure conforming to national guidelines, as determined by the referring cardiologist |
Device: Adaptive Servo Ventilation
BiPAP autoSV ADVANCED device worn nightly during sleep
Other Names:
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Outcome Measures
Primary Outcome Measures
- The time to the composite outcome of death or first CV hospital admission or new onset atrial fibrillation/flutter requiring anti-coagulation but not hospitalization or delivery of an appropriate shock from an ICD not resulting in hospitalization. [The expected study follow-up period is five years]
The study will end once 540 primary endpoints have occurred. The maximum follow-up period for all randomized subjects is 5 years.
Secondary Outcome Measures
- Time to death from any cause [The expected study follow-up period is 5 years]
The study will end once 540 primary endpoints have occurred.
- Number of cardiovascular hospitalizations per year of follow-up [The minimum time of follow-up is expected to be 2 years. The maximum time of follow-up is expected to be 5 years]
- Number of days alive not hospitalized [Time from randomization to censoring (death, primary event or end of study)]
The number of days the patient is hospitalized are subtracted from the total number of days in the study from randomization. This number will be compared between the 2 groups.
- Changes in left ventricular function [6 months from randomization]
Changes in LV function will be assessed by echocardiography at baseline and at 6 months post randomization
- Changes in plasma BNP levels [6 months from randomization]
Changes in plasma NT-proBNP levels will be assessed at baseline and at 6 months post randomization
- Cardiac resynchronization therapy or defibrillator implantations [Average number of days until first cardiac resynchronization or first defibrillator implantation]
The average number of days from randomization to the first occurrence of CRT or defibrillator implantation will be calculated and compared between each treatment arm.
- Changes in 6 minute walk test distance [6 months from randomization]
Changes in the 6-minute walk distance between baseline and 6 months will be compared between the 2 groups
- Percentage of patients with changes in stages of heart failure and functional class [Values obtained at study termination will be compared to those obtained at randomization]
New York Heart Association classification and AHA/ACC Stages of Heart Failure will be assessed at each visit.
- Changes in apnea/hypopnea index [1 month from randomization]
- Changes in Quality of life assessments [Assessments made at baseline, 1, 6, 12 and every 6 months thereafter]
Minnesota living with Heart Failure Questionnaire and Epworth Sleepiness Scale will be used. Scores will be compared between the 2 groups.
Eligibility Criteria
Criteria
Inclusion Criteria:
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American Heart Association Stage B-D Heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months
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Left Ventricular Ejection Fraction ≤ 45 %
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Optimal medical therapy for heart failure
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No change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization
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Sleep apnea with an AHI ≥ 15. Subjects with obstructive sleep apnea must also have an Epworth Sleepiness Scale score of ≤ 10 and no or mild daytime sleepiness
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Written informed consent
Exclusion Criteria:
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Heart failure due to primary valvular heart disease
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Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease
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Hypertrophic obstructive or restrictive or post partum cardiomyopathy
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Exercise capacity limited by class IV angina pectoris
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Acute MI, cardiac surgery, PCI, AICD, or CRT within 3 months of randomization
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Active myocarditis
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Planned AICD or CRT
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Presence of a left-ventricular assist device
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Transplanted heart or expected to receive a transplanted heart within the next 6 months
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Pregnancy
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Current use of ASV or CPAP or mandibular advancement device for treatment of sleep apnea or treated with any investigational therapy during the last 4 weeks (including approved therapies being used in unapproved indications)
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A clinical history that would interfere with the objectives of this study or that would in the investigator's opinion preclude safe conclusion of the study
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Any other medical, social, or geographical factor, which would make it unlikely that the patient will comply with the study procedures (e.g. alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or history of non-compliance)
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Any contraindication to ASV therapy as detailed in the device provider manual
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Arizona/Southern Arizona VA Health Care System | Tucson | Arizona | United States | 85723 |
2 | Glacier View Research Institute, Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
3 | MetroHealth Medical Centre | Cleveland | Ohio | United States | 44109-1998 |
4 | Pronto Socorro Cardiologico de Pernambuco | Recife | Pernambuco | Brazil | CEP 50100-060 |
5 | Instituto Dante Pazzanese de Cardiologia | São Paulo | SP | Brazil | CEP 04012-909 |
6 | CDEC Brasil - Centro de Desenvolvimento em Estudos Clínicos Brasil | São Paulo | SP | Brazil | CEP 04020-060 |
7 | Instituto do Coração do Hospital das Clínicas da FMUSP | São Paulo | SP | Brazil | CEP 05403-000 |
8 | Vancouver General Hospital/UBC/VCHA | Vancouver | British Columbia | Canada | V5Z 1M9 |
9 | St. Boniface General Hospital | Winnipeg | Manitoba | Canada | R2H 2A6 |
10 | Capital District Health Authority | Halifax | Nova Scotia | Canada | B3H 2E2 |
11 | McMaster University Medical Centre, Hamilton Health Sciences | Hamilton | Ontario | Canada | L8S 2X2 |
12 | Kingston General Hospital Sleep Disorders Laboratory/Queen's University | Kingston | Ontario | Canada | K7L 2V6 |
13 | St. Mary's General Hospital | Kitchener | Ontario | Canada | N2M 1B2 |
14 | London Health Sciences Centre - Victoria Hospital | London | Ontario | Canada | N6C 2R5 |
15 | University of Ottawa-Ottawa Heart Institute | Ottawa | Ontario | Canada | K1Y 4W7 |
16 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
17 | University Health Network/TRI/Mount Sinai | Toronto | Ontario | Canada | M5G 2C4 |
18 | Hôpital Hôtel-Dieu du CHUM | Montreal | Quebec | Canada | H2X 0C1 |
19 | McGill University Health Centre, Glen Site | Montreal | Quebec | Canada | H4A 3J1 |
20 | Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval | Quebec City | Quebec | Canada | G1V 4G5 |
21 | Pole d'exploration de L' apnée du sommeil, Nouvelle Clinique Bel Air | Bordeaux | France | 33200 | |
22 | Groupe Hospitalier Ambroise Paré, AP-HP | Boulogne-Billancourt | France | 92100 | |
23 | Centre Hospitalier de Béziers | Béziers | France | 34500 | |
24 | Hôpital Antoine Béclère, AP-HP | Clamart | France | 92141 | |
25 | Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires, Centre Hospitalier Universitaire de Grenoble | Grenoble | France | 38043 | |
26 | Hôpital Bichat- Claude Bernard, AP-HP | Paris | France | 75018 | |
27 | Groupe Hospitalier Pitié-Salpêtrière Charles Foix, AP-HP | Paris | France | 75651 | |
28 | University of Regensburg | Regensburg | Bavaria | Germany | 93053 |
29 | Wissenschaftliches Institut Bethanien e.V. | Solingen | Germany | 42699 | |
30 | ASST Franciacorta, Ospedale di Chiari | Chiari | BS | Italy | 25032 |
31 | Prima Medicina-Spedali Civili | Brescia | Italy | 25123 | |
32 | Istituto Auxologico Italiano - Ospedale San Luca | Milano | Italy | 20149 | |
33 | Istituto Scientifico di Montescano, Istituti Clinici Scientifici Maugeri (ICS Maugeri) | Pavia | Italy | 27040 | |
34 | Istituto Scientifico di Veruno, Istituti Clinici Scientifici Maugeri | Veruno | Italy | 28010 | |
35 | Saiseikai Futsukaichi Hospital | Fukuoka | Japan | 818-8516 | |
36 | Kyoto University Hospital | Kyoto | Japan | 606-8507 | |
37 | Toranomon Hospital | Tokyo | Japan | 105-8470 | |
38 | Juntendo University School of Medicine | Tokyo | Japan | 113-8421 | |
39 | Tokyo Medical University Hospital | Tokyo | Japan | 160-0023 | |
40 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | 08025 | |
41 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
42 | Hospital San Pedro de Alcántara | Cáceres | Spain | 10003 | |
43 | Hospital Arnau de Vilanova | Lleida | Spain | 25198 | |
44 | Fundación Jiménez Diaz-CAPIO | Madrid | Spain | 28040 | |
45 | Hospital Universitario Marques de Valdecilla | Santander | Spain | 39008 | |
46 | Hospital Universitario Rio Hortega | Valladolid | Spain | 47012 | |
47 | Hospital Universitario Miguel Servet | Zaragoza | Spain | 50009 | |
48 | Hospital Universitario Txagorritxu | Vitoria | Álava | Spain | 01009 |
49 | The Sleep Disorders Centre -Nuffield House, Guy's Hospital | London | United Kingdom | SE1 9RT |
Sponsors and Collaborators
- Toronto Rehabilitation Institute
- Canadian Institutes of Health Research (CIHR)
- Philips Respironics
Investigators
- Study Chair: Douglas Bradley, M.D., Toronto Rehabilitation Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADVENT-HF trial