Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy (PACE-nHCM)

Montefiore Medicine Academic Health System

Status: Enrolling

Conditions: Non-obstructive Hypertrophic Cardiomyopathy; Hypertrophic Cardiomyopathy

Treatments: Other: myPACE+ algorithm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06775886

2024-16244

Details and patient eligibility

About

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.

Full 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. An interim data safety analysis will be conducted.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

myPACE+

Experimental group

Description:

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

Treatment:

Other: myPACE+ algorithm

Usual Care

No Intervention group

Description:

Standard of care. Participants will retain a standard pacing lower rate setting of 60 beats per minute (bpm).