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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-obstructive Hypertrophic Cardiomyopathy Hypertrophic Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Researchers collecting pacemaker-detected endpoints cannot be blinded to the rate setting.

Study Groups

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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

Group Type EXPERIMENTAL

myPACE+ algorithm

Intervention Type OTHER

myPACE+ algorithm with mono-fractional exponent

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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myPACE+ algorithm

myPACE+ algorithm with mono-fractional exponent

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No