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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Sleep Apnea; Heart Failure	Device: Adaptive Servo Ventilation	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	860 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	May 2010
Estimated Primary Completion Date :	June 2020
Estimated Study Completion Date :	June 2020

Arms and Interventions

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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	Device: Adaptive Servo Ventilation; BiPAP autoSV ADVANCED device worn nightly during sleep; Other Names: BiPAP autoSV ADVANCED; ASV; Respironics

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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 ]
3. 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.
4. 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
5. 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. 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.
7. 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
8. 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.
9. Changes in apnea/hypopnea index [ Time Frame: 1 month from randomization ]
10. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

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Contacts

Contact: Maggie Szeto	416-597-3422 ext 7721	Maggie.Szeto@uhn.ca

  Show 55 Study Locations

Sponsors and Collaborators

Toronto Rehabilitation Institute

Canadian Institutes of Health Research (CIHR)

Philips Respironics

Investigators

Study Chair:	Douglas Bradley, M.D.	Toronto Rehabilitation Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Douglas Bradley, Study Chairman, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:	NCT01128816 History of Changes
Other Study ID Numbers:	ADVENT-HF trial
First Posted:	May 24, 2010
Last Update Posted:	December 15, 2017
Last Verified:	December 2017

Keywords provided by Douglas Bradley, Toronto Rehabilitation Institute:

obstructive sleep apnea; central sleep apnea; heart failure	congestive heart failure; adaptive servo ventilation; ASV

Additional relevant MeSH terms:

Heart Failure; Apnea; Sleep Apnea Syndromes; Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases	Signs and Symptoms, Respiratory; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases