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

NCT ID: NCT01128816

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 732 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2022-03-31

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.

Conditions

Sleep Apnea; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard HF therapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

Adaptive Servo Ventilation

Intervention Type: DEVICE

BiPAP autoSV ADVANCED device worn nightly during sleep

Interventions

Adaptive Servo Ventilation

BiPAP autoSV ADVANCED device worn nightly during sleep

Intervention Type: DEVICE

Other Intervention Names

BiPAP autoSV ADVANCED; ASV; Respironics

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Philips Respironics

INDUSTRY

Sponsor Role: collaborator

Toronto Rehabilitation Institute

OTHER

Sponsor Role: lead

Responsible Party

Douglas Bradley

Study Chairman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas Bradley, M.D.

Role: STUDY_CHAIR

Toronto Rehabilitation Institute

Locations

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

McMaster University Medical Centre, Hamilton Health Sciences

Hamilton, Ontario, Canada

Kingston General Hospital Sleep Disorders Laboratory/Queen's University

Kingston, Ontario, Canada

St. Mary's General Hospital

Kitchener, Ontario, Canada

London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada

University of Ottawa-Ottawa Heart Institute

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

University Health Network/TRI/Mount Sinai

Toronto, Ontario, Canada

Hôpital Hôtel-Dieu du CHUM

Montreal, Quebec, Canada

McGill University Health Centre, Glen Site

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval

Québec, Quebec, Canada

Centre Hospitalier de Béziers

Béziers, , France

Pole d'exploration de L' apnée du sommeil, Nouvelle Clinique Bel Air

Bordeaux, , France

Groupe Hospitalier Ambroise Paré, AP-HP

Boulogne-Billancourt, , France

Hôpital Antoine Béclère, AP-HP

Clamart, , France

Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires, Centre Hospitalier Universitaire de Grenoble

Grenoble, , France

Hôpital Bichat- Claude Bernard, AP-HP

Paris, , France

Groupe Hospitalier Pitié-Salpêtrière Charles Foix, AP-HP

Paris, , France

University of Regensburg

Regensburg, Bavaria, Germany

Wissenschaftliches Institut Bethanien e.V.

Solingen, , Germany

ASST Franciacorta, Ospedale di Chiari

Chiari, BS, Italy

Prima Medicina-Spedali Civili

Brescia, , Italy

Istituto Auxologico Italiano - Ospedale San Luca

Milan, , Italy

Istituto Scientifico di Montescano, Istituti Clinici Scientifici Maugeri (ICS Maugeri)

Pavia, , Italy

Istituto Scientifico di Veruno, Istituti Clinici Scientifici Maugeri

Veruno, , Italy

Saiseikai Futsukaichi Hospital

Fukuoka, , Japan

Kyoto University Hospital

Kyoto, , Japan

Toranomon Hospital

Tokyo, , Japan

Juntendo University School of Medicine

Tokyo, , Japan

Tokyo Medical University Hospital

Tokyo, , Japan

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital San Pedro de Alcántara

Cáceres, , Spain

Hospital Arnau de Vilanova

Lleida, , Spain

Fundación Jiménez Diaz-CAPIO

Madrid, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Hospital Universitario Rio Hortega

Valladolid, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Hospital Universitario Txagorritxu

Vitoria-Gasteiz, Álava, Spain

The Sleep Disorders Centre -Nuffield House, Guy's Hospital

London, , United Kingdom

Countries

United States; Brazil; Canada; France; Germany; Italy; Japan; Spain; United Kingdom

References

Horvath CM, Fisser C, Floras JS, Sossalla S, Wang S, Tomlinson G, Rankin F, Yatsu S, Ryan CM, Bradley TD, Arzt M; ADVENT-HF Investigators. Nocturnal Cardiac Arrhythmias in Heart Failure With Obstructive and Central Sleep Apnea. Chest. 2024 Dec;166(6):1546-1556. doi: 10.1016/j.chest.2024.08.003. Epub 2024 Aug 20.

Reference Type: DERIVED

PMID: 39168180 (View on PubMed)

Bradley TD, Logan AG, Lorenzi Filho G, Kimoff RJ, Duran Cantolla J, Arzt M, Redolfi S, Parati G, Kasai T, Dunlap ME, Delgado D, Yatsu S, Bertolami A, Pedrosa R, Tomlinson G, Marin Trigo JM, Tantucci C, Floras JS; ADVENT-HF Investigators. Adaptive servo-ventilation for sleep-disordered breathing in patients with heart failure with reduced ejection fraction (ADVENT-HF): a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial. Lancet Respir Med. 2024 Feb;12(2):153-166. doi: 10.1016/S2213-2600(23)00374-0. Epub 2023 Dec 21.

Reference Type: DERIVED

PMID: 38142697 (View on PubMed)

Perger E, Inami T, Lyons OD, Alshaer H, Smith S, Floras JS, Logan AG, Arzt M, Duran Cantolla J, Delgado D, Fitzpatrick M, Fleetham J, Kasai T, Kimoff RJ, Leung RST, Lorenzi Filho G, Mayer P, Mielniczuk L, Morrison DL, Parati G, Parthasarathy S, Redolfi S, Ryan CM, Series F, Tomlinson GA, Woo A, Bradley TD; ADVENT-HF Investigators. Distinct Patterns of Hyperpnea During Cheyne-Stokes Respiration: Implication for Cardiac Function in Patients With Heart Failure. J Clin Sleep Med. 2017 Nov 15;13(11):1235-1241. doi: 10.5664/jcsm.6788.

Reference Type: DERIVED

PMID: 29065956 (View on PubMed)

Other Identifiers

ADVENT-HF trial

Identifier Type: -

Identifier Source: org_study_id