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ASV Therapy for Heart Failure and Sleep Apnea (AMEND Trial)

N/A

Waitlist Available

Led By Rob S Beanlands, MD

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

American Heart Association (AHA) Stages B, C and D heart failure due to ischemic, idiopathic or hypertensive causes with systolic dysfunction, ejection fraction (EF) ≤45% by echocardiography

Age >18 years

Must not have

Myocardial infarction, cardiac surgery or angioplasty within 3 months prior to enrollment

A large transmural scar defined on previous perfusion imaging (severe resting perfusion defect (<50% uptake) occupying >25% of the LV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will help determine if long-term ASV therapy has any benefits for people with HF and sleep apnea.

Who is the study for?

This trial is for adults over 18 with heart failure due to ischemic, idiopathic or hypertensive causes and an ejection fraction ≤45%. Participants must have sleep apnea with an Apnea/hypopnea Index ≥15 and be on stable medical therapy. Exclusions include those listed for heart transplant, life expectancy under 6 months, pregnancy, current ASV or CPAP use, awaiting revascularization, recent cardiac events or certain drug uses.

What is being tested?

The study tests the long-term effects of adaptive servo-ventilation (ASV) on myocardial metabolism and sympathetic nerve function in patients with heart failure who also have obstructive (OSA) or central sleep apnea (CSA). It will measure changes in oxidative metabolism using PET imaging and work-metabolic index improvements after six months of ASV therapy.

What are the potential side effects?

While specific side effects are not detailed here, studies involving ASV may lead to discomfort from wearing the device at night. PET scans involve exposure to radiation. The interventions could potentially affect sleep patterns and cardiovascular function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart failure is due to blockage, unknown causes, or high blood pressure with an EF of 45% or less.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a heart attack or any heart surgery in the last 3 months.

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My heart has a large scar affecting more than 25% of its left side.

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I am waiting for a procedure to restore blood flow.

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My heart failure is caused by a problem with my heart valves.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: [C11]Acetate HED PETExperimental Treatment1 Intervention

AMEND is a single centre substudy of the ADVENT-HF trial. This substudy is a clinical physiologic proposal designed to determine the effects of long-term (6 months) ASV on cardiac energetics and SN function in patients with chronic stable HF and sleep apnea extending our previous evaluation of short-term CPAP in patients with OSA and HF. All subjects consenting to the ADVENT primary trial will be eligible to participate in the substudy. Substudy consenting patients will have \[11C\]acetate and \[11C\]HED PET imaging; HR variability; plasma norepinephrine (NE) levels, urine normetanephrine levels within 2 weeks of the sleep study. Baseline measurements will be repeated after 6 months in all patients.

0 / 6Eligibility criteria met