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

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Apr 14, 2014

Keywords

ClinConnect Summary

This clinical trial, called AMEND, is studying how a treatment called Adaptive Servo-Ventilation (ASV) affects heart health in patients who have heart failure and sleep apnea. Sleep apnea is a condition where breathing stops and starts during sleep, and it can make heart failure worse. The researchers want to see if using ASV for six months can improve how the heart uses energy and how the nervous system affects heart function during the day. They are looking for patients who are stable with heart failure, have a specific type of sleep apnea, and are already receiving appropriate medical treatment.

To participate, individuals must be at least 18 years old, have heart failure with a weakened heart function, and have a certain level of sleep apnea. They also need to be willing to use ASV therapy. Participants can expect to undergo various tests to measure heart function and energy use throughout the study. This trial is important because it aims to provide more information on how long-term ASV therapy can help improve heart health and overall well-being for those dealing with both heart failure and sleep apnea.

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Eligibility criteria

• • 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