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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
732

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • 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
  • Canada
    • 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
  • France
      • 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
  • Germany
      • Solingen, Germany, 42699
        • Wissenschaftliches Institut Bethanien e.V.
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • University of Regensburg
  • Italy
      • 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
  • Japan
      • 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
  • Spain
      • 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 Alcantara
      • Lleida, Spain, 25198
        • Hospital Arnau de Vilanova
      • Madrid, Spain, 28040
        • Fundación Jiménez Diaz-CAPIO
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Valladolid, Spain, 47012
        • Hospital Universitario Río Hortega
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Álava
      • Vitoria, Álava, Spain, 01009
        • Hospital Universitario Txagorritxu
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • The Sleep Disorders Centre -Nuffield House, Guy's Hospital
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Toronto Rehabilitation Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Philips Respironics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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