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Could a sleep apnea machine boost heart efficiency? new study investigates

NCT ID NCT02116140

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether long-term use of a breathing device called adaptive servo-ventilation (ASV) can improve how the heart uses energy and how nerves work in people with heart failure and sleep apnea. Researchers will use PET scans to measure heart metabolism and nerve function in 60 participants over six months. The goal is to understand if ASV therapy helps the heart work more efficiently, which could inform better treatments for these conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adaptive servo-ventilation (ASV) therapy
What this could lead to
If successful, this could clarify whether ASV therapy improves heart energy efficiency and nerve function in heart failure patients with sleep apnea, potentially guiding future treatments.
What could go wrong
This is a small, early-stage substudy (60 participants) focused on measuring biological markers, not clinical outcomes. Results may not translate to broader patient benefits or confirm effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jul 2012

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

This study (AMEND) is a single centre substudy of the ADVENT-HF trial (NCT01128816). ADVENT-HF is a RCT that will test the effects of ASV on morbidity and mortality in patients with HF and OSA or CSA. The AMEND 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 Inclusion Criteria: 1. American Heart Association (AHA) Stages B, C and D heart failure due to ischemic, idiopathic or hypertensive causes with; 2. systolic dysfunction, ejection fraction (EF) ≤45% by echocardiography 3. optimal medical therapy conforming to the AHA guidelines (and for this proposal, stable therapy for \>4 weeks) 4. sleep apnea with an Apnea/hypopnea Index ≥15, which will be divided into OSA (\> 50% events obstructive), or CSA (\> 50% of events central in nature)for patients with OSA, an Epworth Sleepiness Scale score of \>10 and no or mild daytime sleepiness (by the International Classification of Sleep Disorders 5. age \>18 years; 6. willingness to receive ASV therapy 7. informed consent Exclusion Criteria: 1. Myocardial infarction, cardiac surgery or angioplasty within 3 months prior to enrollment, 2. listed for heart transplantation, 3. HF due to primary valvular heart disease, 4. pregnancy 5. current use of ASV or CPAP. 6. awaiting revascularization; 7. previous cardiac transplant; 8. life expectancy less than 6 months due to other co-morbidity; 9. a large transmural scar defined on previous perfusion imaging (severe resting perfusion defect (\<50% uptake) occupying \>25% of the LV); 10. concomitant treatment or use of: tricyclic antidepressants, cocaine or drugs which may alter catecholamine uptake. For heart rate variability (HRV) analysis additional exclusions will include: a) a permanent pacemaker; b) atrial fibrillation; c) significant ventricular arrhythmia or sinus node dysfunction; patients may be excluded from HRV analysis and still be eligible for the sub-study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

More trials for these conditions

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