NCT02116140Active, not recruiting

ASV Effects on Myocardial Energetics and Sympathetic Nerve Function in Heart Failure and Sleep Apnea.

Effects of Long Term Adaptive Servo Ventilation Therapy on Myocardial Energetics and Sympathetic Nerve Function in Heart Failure and Sleep Apnea. The AMEND Sub-study

Source: ClinicalTrials.gov · Last updated 20 Nov 2025

Brief summary (registry, in English)

Obstructive sleep apnea (OSA), central sleep apnea (CSA) and heart failure (HF) are states of metabolic demand and sympathetic nervous system (SNS) activation. In patients with sleep apnea and HF, continuous positive airway pressure (CPAP) initially may reduce left ventricular (LV)stroke volume (SV) but subsequently improves and LV function. This may relate to an early beneficial effect on myocardial energetics through early reduction in metabolic demand that subsequently leads to improved efficiency of LV contraction. However, it is not clear whether long-term adaptive servo-ventilation (ASV) favorably affects cardiac energetics. Any such benefit may also relate to reduced sympathetic nervous system (SNS) activation. However its effect on myocardial SNS function is also not well studied. In a pilot study we demonstrated early (6 week) beneficial effects of CPAP in patients with OSA and HF. The current proposal (AMEND) is a unique substudy of the recently funded ADVENT-HF trial (Adaptive Servo Ventilation for Therapy of Sleep Apnea in HeartFailure) (NCT01128816; CIHR; D. Bradley, PI). We propose to evaluate the long-term (6 month) effects of ASV on daytime 1) oxidative metabolism; 2) the work metabolic index (WMI) as an estimate of mechanical efficiency; 3) myocardial sympathetic nerve (SN) pre-synaptic function; and 4) heart rate (HR) variability in patients with HF and coexisting OSA or CSA. In conjunction with echocardiographic measures of LV stroke work, positron emission tomography (PET) derived \[11C\] acetate kinetics will be used as a measure of oxidative metabolism, to determine the WMI. \[11C\] hydroxyephedrine (HED) retention will be used to measure cardiac SN pre-synaptic function. Primary Hypotheses: In patients with chronic stable HF and CSA or OSA without excessive daytime sleepiness (EDS), long-term (6-month) ASV therapy yields: 1. Beneficial effects on daytime myocardial metabolism leading to a reduction in the rate of oxidative metabolism as measured by \[11C\]acetate kinetics using PET imaging; 2. Improvement in energy transduction from oxidative metabolism to stroke work as measured by an increase in the daytime work-metabolic index.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 60 (estimated)
First submitted: 14 Apr 2014
Start date: 1 Jul 2012
Primary completion date: 30 Jun 2026
Lead sponsor: Ottawa Heart Institute Research Corporation
Diseases: Heart failure
NCT number: NCT02116140

What you commit to

Study type: Interventional
Planned participants: 60
From 1 Jul 2012 to the primary completion date, 30 Jun 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Myocardial infarction, cardiac surgery or angioplasty within 3 months prior to enrollment,
previous cardiac transplant;
a large transmural scar defined on previous perfusion imaging (severe resting perfusion defect (\<50% uptake) occupying \>25% of the LV);
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

Other illness

listed for heart transplantation,
HF due to primary valvular heart disease,

Other

pregnancy
current use of ASV or CPAP.
awaiting revascularization;
life expectancy less than 6 months due to other co-morbidity;

Who the study is looking for

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
optimal medical therapy conforming to the AHA guidelines (and for this proposal, stable therapy for \>4 weeks)
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
age \>18 years;
willingness to receive ASV therapy
informed consent

Criteria the registry did not label

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of Ottawa Heart Institute Coordinator of this site? Confirm its status	Ottawa	Canada	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.