ADVENT-HF: Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure

Sponsor
Toronto Rehabilitation Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT01128816
Collaborator
Canadian Institutes of Health Research (CIHR) (Other), Philips Respironics (Industry)
732
49
2
133.5
14.9
0.1

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
  • Device: Adaptive Servo Ventilation
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
732 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-Centre, Randomized Study to Assess the Effects of Adaptive Servo Ventilation (ASV) on Survival and Frequency of Hospital Admissions in Patients With Heart Failure (HF) and Sleep Apnea (SA)-The ADVENT-HF Trial
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Jun 15, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard HF therapy

Subjects will receive optimal standard therapy for heart failure conforming to national guidelines as determined by the referring cardiologist

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:
  • BiPAP autoSV ADVANCED
  • ASV
  • Respironics
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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]

    3. 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.

    4. 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

    5. 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

    6. 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.

    7. 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

    8. 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.

    9. Changes in apnea/hypopnea index [1 month from randomization]

    10. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • American Heart Association Stage B-D Heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months

    • Left Ventricular Ejection Fraction ≤ 45 %

    • Optimal medical therapy for heart failure

    • No change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization

    • 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

    • Written informed consent

    Exclusion Criteria:
    • Heart failure due to primary valvular heart disease

    • Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease

    • Hypertrophic obstructive or restrictive or post partum cardiomyopathy

    • Exercise capacity limited by class IV angina pectoris

    • Acute MI, cardiac surgery, PCI, AICD, or CRT within 3 months of randomization

    • Active myocarditis

    • Planned AICD or CRT

    • Presence of a left-ventricular assist device

    • Transplanted heart or expected to receive a transplanted heart within the next 6 months

    • Pregnancy

    • 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)

    • 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

    • 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)

    • Any contraindication to ASV therapy as detailed in the device provider manual

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Douglas Bradley, Study Chairman, Toronto Rehabilitation Institute
    ClinicalTrials.gov Identifier:
    NCT01128816
    Other Study ID Numbers:
    • ADVENT-HF trial
    First Posted:
    May 24, 2010
    Last Update Posted:
    Jul 15, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by Douglas Bradley, Study Chairman, Toronto Rehabilitation Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 15, 2021