- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01128816
Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure (ADVENT-HF)
November 17, 2022 updated by: Douglas Bradley, Toronto Rehabilitation Institute
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
732
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, CEP 50100-060
- Pronto Socorro Cardiologico de Pernambuco
-
-
SP
-
São Paulo, SP, Brazil, CEP 04012-909
- Instituto Dante Pazzanese de Cardiologia
-
São Paulo, SP, Brazil, CEP 04020-060
- CDEC BRASIL - Centro de Desenvolvimento em Estudos Clínicos Brasil
-
São Paulo, SP, Brazil, CEP 05403-000
- Instituto do Coração do Hospital das Clínicas da FMUSP
-
-
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital/UBC/VCHA
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R2H 2A6
- St. Boniface General Hospital
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 2E2
- Capital District Health Authority
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 2X2
- McMaster University Medical Centre, Hamilton Health Sciences
-
Kingston, Ontario, Canada, K7L 2V6
- Kingston General Hospital Sleep Disorders Laboratory/Queen's University
-
Kitchener, Ontario, Canada, N2M 1B2
- St. Mary's General Hospital
-
London, Ontario, Canada, N6C 2R5
- London Health Sciences Centre - Victoria Hospital
-
Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa-Ottawa Heart Institute
-
Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network/TRI/Mount Sinai
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 0C1
- Hôpital Hôtel-Dieu du CHUM
-
Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre, Glen Site
-
Quebec City, Quebec, Canada, G1V 4G5
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec- Universite Laval
-
-
-
-
-
Bordeaux, France, 33200
- Pole d'exploration de L' apnée du sommeil, Nouvelle Clinique Bel Air
-
Boulogne-Billancourt, France, 92100
- Groupe Hospitalier Ambroise Paré, AP-HP
-
Béziers, France, 34500
- Centre Hospitalier de Beziers
-
Clamart, France, 92141
- Hôpital Antoine Béclère, AP-HP
-
Grenoble, France, 38043
- Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires, Centre Hospitalier Universitaire de Grenoble
-
Paris, France, 75018
- Hôpital Bichat- Claude Bernard, AP-HP
-
Paris, France, 75651
- Groupe Hospitalier Pitié-Salpêtrière Charles Foix, AP-HP
-
-
-
-
-
Solingen, Germany, 42699
- Wissenschaftliches Institut Bethanien e.V.
-
-
Bavaria
-
Regensburg, Bavaria, Germany, 93053
- University of Regensburg
-
-
-
-
-
Brescia, Italy, 25123
- Prima Medicina-Spedali Civili
-
Milano, Italy, 20149
- Istituto Auxologico Italiano - Ospedale San Luca
-
Pavia, Italy, 27040
- Istituto Scientifico di Montescano, Istituti Clinici Scientifici Maugeri (ICS Maugeri)
-
Veruno, Italy, 28010
- Istituto Scientifico di Veruno, Istituti Clinici Scientifici Maugeri
-
-
BS
-
Chiari, BS, Italy, 25032
- ASST Franciacorta, Ospedale di Chiari
-
-
-
-
-
Fukuoka, Japan, 818-8516
- Saiseikai Futsukaichi Hospital
-
Kyoto, Japan, 606-8507
- Kyoto University Hospital
-
Tokyo, Japan, 160-0023
- Tokyo Medical University Hospital
-
Tokyo, Japan, 105-8470
- Toranomon Hospital
-
Tokyo, Japan, 113-8421
- Juntendo University School of Medicine
-
-
-
-
-
Barcelona, Spain, 08025
- Hospital de La Santa Creu i Sant Pau
-
Barcelona, Spain, 08035
- Hospital Universitari Vall D'Hebron
-
Cáceres, Spain, 10003
- Hospital San Pedro de Alcántara
-
Lleida, Spain, 25198
- Hospital Arnau de Vilanova
-
Madrid, Spain, 28040
- Fundación Jiménez Diaz-CAPIO
-
Santander, Spain, 39008
- Hospital Universitario Marques de Valdecilla
-
Valladolid, Spain, 47012
- Hospital Universitario Río Hortega
-
Zaragoza, Spain, 50009
- Hospital Universitario Miguel Servet
-
-
Álava
-
Vitoria, Álava, Spain, 01009
- Hospital Universitario Txagorritxu
-
-
-
-
-
London, United Kingdom, SE1 9RT
- The Sleep Disorders Centre -Nuffield House, Guy's Hospital
-
-
-
-
Arizona
-
Tucson, Arizona, United States, 85723
- University of Arizona/Southern Arizona VA Health Care System
-
-
Montana
-
Kalispell, Montana, United States, 59901
- Glacier View Research Institute, Kalispell Regional Medical Center
-
-
Ohio
-
Cleveland, Ohio, United States, 44109-1998
- MetroHealth Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
BiPAP autoSV ADVANCED device worn nightly during sleep
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 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.
|
The expected study follow-up period is five years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to death from any cause
Time Frame: The expected study follow-up period is 5 years
|
The study will end once 540 primary endpoints have occurred.
|
The expected study follow-up period is 5 years
|
Number of cardiovascular hospitalizations per year of follow-up
Time Frame: The minimum time of follow-up is expected to be 2 years. The maximum time of follow-up is expected to be 5 years
|
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 Frame: 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.
|
Time from randomization to censoring (death, primary event or end of study)
|
Changes in left ventricular function
Time Frame: 6 months from randomization
|
Changes in LV function will be assessed by echocardiography at baseline and at 6 months post randomization
|
6 months from randomization
|
Changes in plasma BNP levels
Time Frame: 6 months from randomization
|
Changes in plasma NT-proBNP levels will be assessed at baseline and at 6 months post randomization
|
6 months from randomization
|
Cardiac resynchronization therapy or defibrillator implantations
Time Frame: 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.
|
Average number of days until first cardiac resynchronization or first defibrillator implantation
|
Changes in 6 minute walk test distance
Time Frame: 6 months from randomization
|
Changes in the 6-minute walk distance between baseline and 6 months will be compared between the 2 groups
|
6 months from randomization
|
Percentage of patients with changes in stages of heart failure and functional class
Time Frame: 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.
|
Values obtained at study termination will be compared to those obtained at randomization
|
Changes in apnea/hypopnea index
Time Frame: 1 month from randomization
|
1 month from randomization
|
|
Changes in Quality of life assessments
Time Frame: 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.
|
Assessments made at baseline, 1, 6, 12 and every 6 months thereafter
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Douglas Bradley, M.D., Toronto Rehabilitation Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
March 31, 2022
Study Completion (Actual)
March 31, 2022
Study Registration Dates
First Submitted
April 26, 2010
First Submitted That Met QC Criteria
May 21, 2010
First Posted (Estimate)
May 24, 2010
Study Record Updates
Last Update Posted (Actual)
November 22, 2022
Last Update Submitted That Met QC Criteria
November 17, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADVENT-HF trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Duke University; St. Paul's Hospital... and other collaboratorsActive, not recruitingHeart Diseases | Heart Failure | Transplant; Failure, Heart | Heart Transplant Failure and Rejection | Heart Failure,Congestive | Transplant FailureCanada, United States
Clinical Trials on Adaptive Servo Ventilation
-
ResMedCRI-The Clinical Research Institute GmbH; University Hospital RegensburgCompletedObstructive Sleep Apnea | Central Sleep Apnea | Mixed Sleep Apnea | Complex Sleep ApneaSwitzerland, Spain, Denmark, Portugal, France, Germany
-
University Hospital, MontpellierCompletedComplex Sleep Apnea Syndrome | Chronic Heart Failure and | Obstructive Sleep Apnea Syndrome and | Idiopathic Central Sleep Apnea Syndrome | Idiopathic Induced Periodic Breathing | Central Sleep Apnea SyndromeFrance
-
Veterans Medical Research FoundationResMed FoundationUnknownHeart Failure | Sleep Apnea, ObstructiveUnited States
-
University Hospital RegensburgResMed FoundationTerminatedSleep Apnea | Acute Myocardial InfarctionGermany
-
Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI); National Center for Research... and other collaboratorsCompleted
-
Rami KhayatPhilips RespironicsTerminatedHeart Failure | Sleep Apnea SyndromesUnited States
-
University Hospital, GrenobleCompletedHeart Failure | Central Sleep Apneas Syndrome | Coronary Artery Bypass Graft Surgery or Other Coronary ReperfusionFrance
-
ResMedTerminatedDiastolic Heart FailureGermany
-
ResMedCompletedSubstudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation (MS)Heart Failure | Sleep Disorder | Cheyne Stokes RespirationAustralia, Germany, Switzerland, Netherlands, France, Finland, Czech Republic, United Kingdom
-
ResMedCompletedCheyne-Stokes Respiration | Periodic BreathingGermany