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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

AMEND Trial 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.Check my eligibility
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.See study design
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.

AMEND Trial 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.
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I have sleep apnea with mostly obstructive events and feel very sleepy during the day.
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I am willing to undergo ASV therapy.
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I have been on stable heart medication for over 4 weeks as per AHA guidelines.

AMEND Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ASV therapy yields a reduction in the rate of oxidative metabolism as measured by [11C]acetate kinetics using PET imaging in patients with HF, OSA and/or CSA
ASV therapy yields an improvement in energy transduction from oxidative metabolism to stroke work as measured by an increase in the daytime work-metabolic index inpatients with HF, OSA and/or CSA.
Secondary outcome measures
ASV for CSA or OSA in patients with HF and sleep apnea will normalize daytime myocardial SN pre-synaptic function measured by [11C]HED retention on PET imaging
ASV for CSA or OSA in patients with HF and sleep apnea will normalize daytime sympathetic contributions to heart rate variability

AMEND 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
188 Previous Clinical Trials
92,514 Total Patients Enrolled
18 Trials studying Heart Failure
11,084 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for individuals to join this research endeavor?

"As indicated on clinicaltrials.gov, this medical study is not currently recruiting patients; the trial was originally posted to the website on July 1st 2012 and last edited October 11th 2022. Nevertheless, there are still 992 other trials actively seeking participants at present."

Answered by AI
~1 spots leftby Jun 2024