myPACE+ Algorithm for Hypertrophic Cardiomyopathy

(PACE-nHCM Trial)

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach for individuals with hypertrophic cardiomyopathy, specifically those whose hearts pump normally but experience heart failure symptoms. The study compares personalized accelerated pacing using the myPACE+ algorithm, a specialized pacing strategy, to usual care to determine if it improves symptoms, heart function, and overall quality of life. Participants will either have their heart's pacing adjusted based on the algorithm or continue with standard pacing. This trial suits individuals with non-obstructive hypertrophic cardiomyopathy, normal heart pumping action, and dual-chamber defibrillators already in place. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance treatment options for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the myPACE+ algorithm is safe for patients with hypertrophic cardiomyopathy?

Research has shown that personalized accelerated pacing, such as the myPACE+ algorithm, is generally safe. Studies have found that this method can enhance heart health and exercise ability without major safety concerns. No specific reports of serious side effects have been linked to myPACE+, indicating that patients tolerate the treatment well. However, as with any new treatment, individual experiences may vary, so discussing potential risks with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the myPACE+ algorithm for hypertrophic cardiomyopathy because it offers a personalized approach to pacing heart rates. Unlike the standard treatment, which typically maintains a fixed heart rate setting of 60 beats per minute, the myPACE+ algorithm adjusts the pacing based on each individual's resting heart rate. This tailored method could potentially improve heart function and quality of life for patients by aligning more closely with their unique physiological needs. By focusing on personalized care, myPACE+ might provide a more effective management strategy for those with hypertrophic cardiomyopathy.

What evidence suggests that the myPACE+ algorithm is effective for hypertrophic cardiomyopathy?

Research has shown that the myPACE+ algorithm can assist people with hypertrophic cardiomyopathy (HCM), a condition where the heart muscle thickens excessively. In this trial, participants in the myPACE+ arm will receive a personalized lower rate setting based on the myPACE+ resting heart rate algorithm. The myPACE trial found that using this algorithm for personalized pacing significantly improved quality of life. Specifically, participants reported feeling better and experiencing fewer heart failure symptoms. Although specific data from the study is not provided here, these early results suggest that the myPACE+ algorithm could be a promising tool for managing symptoms in HCM patients. ^{3 4 6 7 8}

Who Is on the Research Team?

Sandhya Murthy, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. withpower.com withpower.com/trial/phase-cardiomyopathies-1-2025-2bd85

myPACE+ Algorithm for Hypertrophic Cardiomyopathy The investigator team hypothesizes that personalized accelerated pacing will be safe and improve symptoms and heart-failure related quality of life, physical ...

2. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2023/03/03/15/52/mypace

Personalized Pacing: A New Paradigm for Patients With ... The myPACE trial showed that a personalized accelerated pacing rate (myPACE) resulted in significant improvements in health-related quality of life.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12189642/

A Narrative Review of Current and Investigational ... This review aims to provide a concise overview of both currently approved and investigational treatments for hypertrophic cardiomyopathy.

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Cardiomyopathy%2C%20Hypertrophic%22

San Mateo Clinical Trials This study will examine the effectiveness of the drug cyclosporine in treating hypertrophic cardiomyopathy (HCM), a condition in which the heart muscle thickens ...

5. hcplive.com hcplive.com/view/ai-algorithm-used-to-predict-odds-of-hypertrophic-cardiomyopathy

AI Algorithm Used to Predict Odds of Hypertrophic ... This advancement in AI tools aims to improve patient outcomes by integrating into clinical workflows and preventing adverse HCM-related events.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06775886

NCT06775886 | Effect of Personalized Accelerated Pacing ... The investigator team hypothesizes that personalized accelerated pacing will be safe and improve symptoms and heart-failure related quality of life, physical ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2024.01.036

Effect of Personalized Accelerated Pacing in Patients With ... Personalized accelerated pacing for 3 months improves heart failure related health status, exercise capacity, and reduces left atrial volume.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12539420/

Cardiac Myosin Inhibitors in Hypertrophic Cardiomyopathy Significantly reduced LVOT gradient, improved patient symptoms and NYHA class, and exhibited good safety compared to placebo. 2024-2025. Large- ...