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

Heart Failure Clinical Trial

— ADVENT-HF  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01128816
• Other study ID #: ADVENT-HF trial
• Status: Terminated
• Phase: N/A
• Start date: May 2010
• Est. completion date: March 31, 2022

Study information

• Verified date: November 2022
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 732
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Heart Failure
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• Adaptive Servo Ventilation
BiPAP autoSV ADVANCED device worn nightly during sleep

Locations

Country	Name	City	State
Brazil	Pronto Socorro Cardiologico de Pernambuco	Recife	Pernambuco
Brazil	CDEC Brasil - Centro de Desenvolvimento em Estudos Clínicos Brasil	São Paulo	SP
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo	SP
Brazil	Instituto do Coração do Hospital das Clínicas da FMUSP	São Paulo	SP
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	Hôpital Hôtel-Dieu du CHUM	Montreal	Quebec
Canada	McGill University Health Centre, Glen Site	Montreal	Quebec
Canada	University of Ottawa-Ottawa Heart Institute	Ottawa	Ontario
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval	Quebec City	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	University Health Network/TRI/Mount Sinai	Toronto	Ontario
Canada	Vancouver General Hospital/UBC/VCHA	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
France	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	Groupe Hospitalier Pitié-Salpêtrière Charles Foix, AP-HP	Paris
France	Hôpital Bichat- Claude Bernard, AP-HP	Paris
Germany	University of Regensburg	Regensburg	Bavaria
Germany	Wissenschaftliches Institut Bethanien e.V.	Solingen
Italy	Prima Medicina-Spedali Civili	Brescia
Italy	ASST Franciacorta, Ospedale di Chiari	Chiari	BS
Italy	Istituto Auxologico Italiano - Ospedale San Luca	Milano
Italy	Istituto Scientifico di Montescano, Istituti Clinici Scientifici Maugeri (ICS Maugeri)	Pavia
Italy	Istituto Scientifico di Veruno, Istituti Clinici Scientifici Maugeri	Veruno
Japan	Saiseikai Futsukaichi Hospital	Fukuoka
Japan	Kyoto University Hospital	Kyoto
Japan	Juntendo University School of Medicine	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
Japan	Toranomon Hospital	Tokyo
Spain	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 Txagorritxu	Vitoria	Álava
Spain	Hospital Universitario Miguel Servet	Zaragoza
United Kingdom	The Sleep Disorders Centre -Nuffield House, Guy's Hospital	London
United States	MetroHealth Medical Centre	Cleveland	Ohio
United States	Glacier View Research Institute, Kalispell Regional Medical Center	Kalispell	Montana
United States	University of Arizona/Southern Arizona VA Health Care System	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	Canadian Institutes of Health Research (CIHR), Philips Respironics

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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	Time to death from any cause	The study will end once 540 primary endpoints have occurred.	The expected study follow-up period is 5 years
Secondary	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
Secondary	Number of days alive not hospitalized	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)
Secondary	Changes in left ventricular function	Changes in LV function will be assessed by echocardiography at baseline and at 6 months post randomization	6 months from randomization
Secondary	Changes in plasma BNP levels	Changes in plasma NT-proBNP levels will be assessed at baseline and at 6 months post randomization	6 months from randomization
Secondary	Cardiac resynchronization therapy or defibrillator implantations	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
Secondary	Changes in 6 minute walk test distance	Changes in the 6-minute walk distance between baseline and 6 months will be compared between the 2 groups	6 months from randomization
Secondary	Percentage of patients with changes in stages of heart failure and functional class	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
Secondary	Changes in apnea/hypopnea index		1 month from randomization
Secondary	Changes in Quality of life assessments	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