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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

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 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

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.

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Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
193 Previous Clinical Trials
92,832 Total Patients Enrolled
21 Trials studying Heart Failure
11,220 Patients Enrolled for Heart Failure
Rob S Beanlands, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
3 Previous Clinical Trials
25,915 Total Patients Enrolled

Media Library

[C11]Acetate and HED PET Clinical Trial Eligibility Overview. Trial Name: NCT02116140 — N/A
Heart Failure Research Study Groups: [C11]Acetate HED PET
Heart Failure Clinical Trial 2023: [C11]Acetate and HED PET Highlights & Side Effects. Trial Name: NCT02116140 — N/A
[C11]Acetate and HED PET 2023 Treatment Timeline for Medical Study. Trial Name: NCT02116140 — N/A
~5 spots leftby Sep 2025
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