Paced Heart Rate Acceleration for Cardiac Conditioning
United States52 participantsStarted 2024-06-26
Plain-language summary
A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed. The study population comprises subjects with guideline-directed medically managed left ventricular dysfunction due to ischemic or non-ischemic cardiomyopathy and an existing implantable cardioverter defibrillator or biventricular implantable cardioverter defibrillator. The purpose of the study is to understand how the heart rate pattern of exercise contributes to the considerable cardiac conditioning effects of exercise and estimate whether the pacing approach may have translational clinical applicability. Fifty-two subjects will be randomized, single-blinded, to either the pacing intervention or a sham intervention which they will receive once daily, 3 days/week for 6 weeks. Baseline symptoms and clinical test results will be compared to the same measures at 2 weeks, 4 weeks and 6 weeks of intervention/sham and at 3 months and one-year post-intervention. The primary endpoint will be the change in left ventricular ejection fraction from baseline in intervention vs. sham groups (mixed effects linear regression with time and treatment arm as fixed effects and pre-specified covariates of sex and cardiomyopathy type as random effects). Secondary endpoints will include changes in quality of life, 6-minute walk distance, cardiopulmonary exercise test (CPET) measures, daily activity and major adverse cardiac events (MACE) at 3 and 12 months between pacing and sham groups. A "dose-response" analysis of outcomes at 2, 4, and 6 weeks of the intervention vs. sham compared with baseline will be performed.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female sex
* Age 18 years or greater
* Available transportation for study visits
* Left ventricular ejection fraction \< or = 40% despite at least 3 months guideline-directed medial therapy
* NYHA class II-III heart failure symptoms
* Atrial-lead inclusive implantable cardioverter defibrillator or biventricular defibrillator in place \> 3 months
* Intrinsic or biventricular paced QRS duration of \<= 120 milliseconds
Exclusion Criteria:
* Age \< 18 years
* Inability to ambulate safely
* Congenital or primary valve disease
* Ongoing (not suppressed) atrial arrhythmias
* Left ventricular thrombus
* Severe peripheral arterial disease that limits mobility
* Hospital admission for life-threatening condition (e.g. heart failure, stroke) in the past 3 months
* Major surgery in the past 3 months or anticipated during the period of study
* Ventricular pacing indication in the absence of biventricular pacing
* Life expectancy \< 1 year
* Hemodialysis
* Hematocrit \< 30%
* Severe chronic lung disease that limits activity or requires oxygen
* Pregnancy
* Implantable cardioverter defibrillator battery longevity \< 1 year
* Vulnerable populations such as prisoners and institutionalized individuals
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in left ventricular ejection fraction by echocardiogram
Timeframe: at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham.