Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy
Launched by MONTEFIORE MEDICAL CENTER · Jan 9, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The clinical trial is investigating a new treatment approach called personalized accelerated pacing for patients with a condition known as non-obstructive hypertrophic cardiomyopathy (nHCM). This heart condition can cause symptoms like shortness of breath and fatigue. The trial will involve patients who have certain heart function measurements and are experiencing moderate to severe symptoms. Participants will be randomly assigned to receive either the personalized pacing or standard care, and their heart health will be assessed through tests and questionnaires at the beginning and after three months.
To be eligible for this trial, patients must have a specific type of hypertrophic cardiomyopathy without a significant blockage in blood flow, a certain level of heart function, and a normal heart conduction system. They also need to have a compatible implantable cardioverter defibrillator (ICD) already in place. Throughout the trial, participants can expect to undergo various tests to evaluate their heart function, symptoms, and overall quality of life. This study aims to see if the personalized pacing can improve their symptoms and heart health compared to usual care.
Gender
ALL
Eligibility 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
About Montefiore Medical Center
Montefiore Medical Center is a leading academic medical institution located in the Bronx, New York, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a principal sponsor of clinical studies, Montefiore fosters a collaborative environment that connects researchers, healthcare professionals, and patients to explore cutting-edge therapies and improve health outcomes. With a strong emphasis on patient-centered care, the center integrates its extensive clinical expertise with robust research capabilities to address a wide range of medical conditions, contributing significantly to the advancement of medical science and clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bronx, New York, United States
Patients applied
Trial Officials
Sandhya Murthy, MD
Principal Investigator
Montefiore Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported