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

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.

Conditions

Non-obstructive Hypertrophic Cardiomyopathy, Hypertrophic Cardiomyopathy

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Non-obstructive Hypertrophic Cardiomyopathy
Intervention / Treatment

-

Contacts and Locations

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10467

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Montefiore Medical Center,

Sandhya Murthy, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

2027-03