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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack or any heart surgery in the last 3 months.My heart has a large scar affecting more than 25% of its left side.My heart failure is due to blockage, unknown causes, or high blood pressure with an EF of 45% or less.I am older than 18 years.I am waiting for a procedure to restore blood flow.You have another health problem that is likely to make you live for less than six months.I am not using tricyclic antidepressants, cocaine, or drugs affecting catecholamine uptake.I do not have a pacemaker, atrial fibrillation, or significant heart rhythm problems.I have sleep apnea with mostly obstructive events and feel very sleepy during the day.I am willing to undergo ASV therapy.You are currently using ASV or CPAP.You are on the waiting list for a heart transplant.I have been on stable heart medication for over 4 weeks as per AHA guidelines.You have had a heart transplant in the past.My heart failure is caused by a problem with my heart valves.
Research Study Groups:
This trial has the following groups:- Group 1: [C11]Acetate HED PET
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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