Personalized pacing for patients with non-obstructive hypertrophic cardiomyopathy
Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy
This study is testing if a personalized heart pacing method can help people with non-obstructive hypertrophic cardiomyopathy feel better and improve their quality of life compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (Bronx, New York) |
| Trial ID | NCT06775886 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of personalized accelerated pacing on patients with non-obstructive hypertrophic cardiomyopathy (nHCM) who have a left ventricular ejection fraction of 50% or higher and experience moderate symptoms. Participants will be randomly assigned to receive either personalized pacing using the myPACE+ algorithm or standard care. The study will assess various outcomes, including heart failure symptoms, quality of life, physical activity, and cardiac biomarkers, through tests such as cardiopulmonary exercise testing and echocardiograms. An interim safety analysis will also be conducted to ensure participant safety throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are patients with non-obstructive hypertrophic cardiomyopathy, a left ventricular ejection fraction of 50% or higher, and moderate symptoms.
Not a fit: Patients with obstructive hypertrophic cardiomyopathy or those with significant comorbidities that affect heart function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve symptoms and quality of life for patients with non-obstructive hypertrophic cardiomyopathy.
How similar studies have performed: While personalized pacing approaches have been explored, this specific application in non-obstructive hypertrophic cardiomyopathy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Non obstructive HCM: Left Ventricular Outflow Tract (LVOT) gradient \<30mmHg at rest and with provocation * Left ventricular ejection fraction (LVEF) ≥50% * New York Heart Association (NYHA II-III) symptoms * Normal intrinsic conduction system * Suitable dual-chamber implantable cardioverter defibrillators (ICD) system Exclusion Criteria: * Pregnancy * LVEF \<50% * LVOT gradient \> 30mmHg at rest or with provocation * Prolonged PR \> 250ms * Baseline RV-pacing burden of \> 1% more than moderate valvular stenosis or regurgitation * Aortic valve replacement in the past one year * Significant primary pulmonary disease on home oxygen * Uncontrolled hypertension as defined by BP \>160/100 mmHg on two measurements ≥15 minutes apart
Where this trial is running
Bronx, New York
- Montefiore Medical Center — Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sandhya Murthy, MD — Montefiore Medical Center
- Study coordinator: Sandhya Murthy, MD
- Email: smurthy@montefiore.org
- Phone: 718-920-2248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.