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Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure | Clinical Trials | Clareo Health

TERMINATEDNA

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

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

NCT01128816•Toronto Rehabilitation Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (49)

University of Arizona/Southern Arizona VA Health Care System

Tucson, Arizona, United States

Glacier View Research Institute, Kalispell Regional Medical Center

Kalispell, Montana, United States

MetroHealth Medical Centre

Cleveland, Ohio, United States

Pronto Socorro Cardiologico de Pernambuco

Recife, Pernambuco, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

CDEC Brasil - Centro de Desenvolvimento em Estudos Clínicos Brasil

São Paulo, São Paulo, Brazil

Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, São Paulo, Brazil

Vancouver General Hospital/UBC/VCHA

Vancouver, British Columbia, Canada

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Capital District Health Authority

Halifax, Nova Scotia, Canada

Key Dates

Start Date

May 1, 2010

Primary Completion Date

March 31, 2022

Completion Date

March 31, 2022

Last Updated

November 22, 2022

Enrollment

732

ACTUAL participants

Conditions

Sleep ApneaHeart Failure

Interventions

Adaptive Servo Ventilation

DEVICE

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

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