myPACE+ Algorithm for Hypertrophic Cardiomyopathy

(PACE-nHCM Trial)

Overseen By Adaya Weissler Snir, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Pregnancy, LVEF <50%, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sandhya Murthy, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

This trial is for patients with non-obstructive hypertrophic cardiomyopathy (nHCM), who have symptoms of heart failure but a normal heart pump function (LVEF ≥50%) and are in NYHA class II-III. They must already have a suitable dual-chamber ICD system installed.

Inclusion Criteria

My heart pumps blood effectively.

My heart's electrical system is normal.

I have a suitable dual-chamber ICD system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments including CPET, echocardiogram, blood work for NT-proBNP levels, and completion of KCCQ-OSS and HCMSQ questionnaires

1 week

1 visit (in-person)

Treatment

Participants receive either personalized accelerated pacing or usual care for 3 months

12 weeks

Continuous monitoring via pacemaker

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up assessments of CPET, echocardiogram, and blood work

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• myPACE+ algorithm

Trial Overview The study tests personalized accelerated pacing using the myPACE+ algorithm against usual care in people with nHCM. It aims to see if this method improves symptoms, quality of life, physical activity levels, oxygen uptake during exercise, biomarkers like NT-proBNP, and heart structure/function.

Participant Groups

Group I: myPACE+ Experimental Treatment 1 Intervention

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 II: Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc