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

Toronto Rehabilitation Institute

Status: Terminated

Conditions: Sleep Apnea; Heart Failure

Treatments: Device: Adaptive Servo Ventilation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01128816

ADVENT-HF trial

Details and patient eligibility

About

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.

Enrollment: 732 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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732 participants in 2 patient groups

Standard HF therapy

No Intervention group

Description:

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

Standard therapy for HF + ASV

Active Comparator group

Description:

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

Treatment:

Device: Adaptive Servo Ventilation