RecruitingNCT07864558ClinicalTrials.gov record

PrEcision Pacing in HFpEF: the PEP-HFpEF Trial

Heart Failure and Preserved Ejection Fraction · Heart Failure New York Heart Association Class III · Heart Failure New York Heart Association (NYHA) Class II

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 36 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

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.

Device: Individualized myPACE pacemaker programming

Individualized myPACE pacemaker programming DEVICE

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.

Prepare your questions