RECRUITING

Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This will be a two-arm investigator-initiated randomized controlled study of patients with nHCM and LV ejection fraction ≥50% and NYHA II-III symptoms, normal intrinsic conduction system and pre-existing suitable dual-chamber implantable cardioverter defibrillators (ICD) systems. Patients will be randomly assigned to either personalized accelerated pacing (using the myPACE+ algorithm with mono-fractional exponent) or usual care groups. At baseline and after 3 months of pacing all patients will undergo a CPET, echocardiogram, blood work for NT-proBNP levels and complete the KCCQ-OSS and HCMSQ, questionnaires. The investigator team hypothesizes that personalized accelerated pacing will be safe and improve symptoms and heart-failure related quality of life, physical activity, pVO2, biomarkers (i.e. NT-proBNP), diastolic parameters and cardiac structure.

Official Title

Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy

Quick Facts

Study Start:2025-03
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06775886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Non obstructive HCM: Left Ventricular Outflow Tract (LVOT) gradient \<30mmHg at rest and with provocation
  2. * Left ventricular ejection fraction (LVEF) ≥50%
  3. * New York Heart Association (NYHA II-III) symptoms
  4. * Normal intrinsic conduction system
  5. * Suitable dual-chamber implantable cardioverter defibrillators (ICD) system
  1. * Pregnancy
  2. * LVEF \<50%
  3. * LVOT gradient \> 30mmHg at rest or with provocation
  4. * Prolonged PR \> 250ms
  5. * Baseline RV-pacing burden of \> 1% more than moderate valvular stenosis or regurgitation
  6. * Aortic valve replacement in the past one year
  7. * Significant primary pulmonary disease on home oxygen
  8. * Uncontrolled hypertension as defined by BP \>160/100 mmHg on two measurements ≥15 minutes apart

Contacts and Locations

Study Contact

Sandhya Murthy, MD
CONTACT
718-920-2248
smurthy@montefiore.org
Adaya Weissler Snir, MD
CONTACT
adayaw@gmail.com

Principal Investigator

Sandhya Murthy, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center
Bronx, New York, 10467
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

  • Sandhya Murthy, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03
Study Completion Date2027-03

Study Record Updates

Study Start Date2025-03
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Cardiomyopathy
  • Personalized Accelerated Pacing
  • Heart Failure with preserved Ejection Fraction (HFpEF)

Additional Relevant MeSH Terms

  • Non-obstructive Hypertrophic Cardiomyopathy
  • Hypertrophic Cardiomyopathy