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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Sandhya Murthy, MD
smurthy@montefiore.org
718-920-2248
Backup
Adaya Weissler Snir, MD
adayaw@gmail.com
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2027-09
Participants
Target number of participants: 40
Treatments
Experimental: myPACE+
Participants will be programmed to a personalized lower rate setting based on the myPACE+ resting heart rate algorithm will be conducted using the myPACE+ algorithm
No_intervention: Usual Care
Standard of care. Participants will retain a standard pacing lower rate setting of 60 beats per minute (bpm).
Sponsors
Collaborators: Medtronic
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov