Recruiting

myPACE

Sponsor:

Tufts Medical Center

Code:

NCT07864558

Conditions

Heart Failure and Preserved Ejection Fraction

Heart Failure New York Heart Association Class III

Heart Failure New York Heart Association (NYHA) Class II

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Individualized myPACE pacemaker programming

Study Details

Brief summary:

The PEP-HFpEF study is a prospective, single-center mechanistic study evaluating personalized heart rate pacing (myPACE) in patients with heart failure with preserved ejection fraction (HFpEF) and existing cardiac physiologic pacemakers. Participants will undergo sequential periods of standard and personalized pacing with serial physiologic assessments to evaluate the effects of myPACE on exercise capacity, cardiac function, biomarkers, quality of life, and clinical outcomes.

Conditions

Heart Failure and Preserved Ejection Fraction

Heart Failure New York Heart Association Class III

Heart Failure New York Heart Association (NYHA) Class II

Study ID

NCT07864558

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years.
  • Diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as left ventricular ejection fraction (LVEF) ≥50% with symptoms and signs consistent with heart failure as determined by the treating investigator.
  • New York Heart Association (NYHA) Class II or III symptoms despite stable, maximally tolerated guideline-directed medical therapy.
  • Pre-existing FDA-approved cardiac physiologic pacemaker (e.g., conduction system pacing or cardiac resynchronization therapy) implanted for a standard clinical indication and capable of individualized lower-rate programming.
  • Expected to require ongoing pacemaker therapy throughout the study period.
  • Clinically stable at enrollment, without recent major changes in heart failure status that, in the opinion of the investigator, would interfere with interpretation of study outcomes.
  • Able and willing to provide written informed consent.
  • Able and willing to comply with all study procedures, including pacemaker programming, cardiopulmonary exercise testing (CPET), echocardiography, blood pressure measurements, autonomic testing, blood collection, and follow-up visits.

Exclusion Criteria:

  • Age <18 years.
  • Left ventricular ejection fraction <50%.
  • Pregnancy, breastfeeding, or women of childbearing potential unwilling to use an acceptable method of contraception during study participation.
  • Inability or unwillingness to provide informed consent.
  • Inability to safely perform study procedures, including CPET or autonomic testing, in the opinion of the investigator.
  • Any medical condition or life expectancy that, in the opinion of the investigator, would make participation unsafe or would substantially interfere with completion of the study or interpretation of study results.
  • Enrollment in another interventional clinical trial that, in the opinion of the investigators, could interfere with this study or confound interpretation of the results.
  • Prisoners, wards of the state, or other individuals for whom participation would not be permissible under applicable regulations or institutional policy.

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Individualized myPACE Pacing

Participants will undergo a 3-month baseline period with their pacemaker programmed to standard-of-care settings (lower rate limit of 60 beats per minute), followed by individualized programming using the myPACE heart-rate algorithm for 12 months. Following completion of the 12-month intervention period, pacemakers will be reprogrammed to standard-of-care settings (60 bpm) for an additional 3 months. Participants will undergo study assessments and monitoring throughout the entire 18-month study period.

Interventions

Individualized myPACE pacemaker programming

The myPACE intervention uses an individualized heart-rate algorithm to determine a personalized pacemaker backup rate within the normal range of adult resting heart rates. The algorithm estimates an individualized resting heart rate based on participant height and left ventricular ejection fraction (LVEF). The algorithm is designed to provide a modest increase in resting heart rate tailored to individual physiologic characteristics, including LVEF.

Primary outcome measure

  • Peak Oxygen Consumption (Peak VO₂) [ Time Frame: Baseline, 12 months ]

Central Contacts and Locations

Central contacts

Courtney Uek

617-636-4354courtney.uek@tuftsmedicine.org

Locations

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Courtney Uek

617-636-4354courtney.uek@tuftsmedicine.org

Margaret.Infeld@tuftsmedicine.org

Principal Investigator:

Margaret Infeld, MD, MS

More Information

Sponsor

Tufts Medical Center

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • HFpEF
  • Heart Failure
  • pacemaker
  • personalized pacing
  • heart failure with preserved ejection fraction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Tufts Medical Center on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.