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.
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.
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.
Single group
Individualized myPACE pacemaker programming
DeviceThe 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.
Peak Oxygen Consumption (Peak VO₂)
Change in peak oxygen consumption (peak VO2) during upright bicycle cardiopulmonary exercise testing (CPET), from conventional 60 bpm pacing (at baseline) to personalized physiologic pacing (myPACE) (at 12 months). Peak VO2 will be measured in mL/kg/min.
Ventilatory Efficiency (VE/VCO₂ Slope)
Change in the VE/VCO₂ slope during upright bicycle CPET from conventional pacing at 60 bpm to personalized physiologic pacing (myPACE).
Oxygen Pulse
Change in oxygen pulse during upright bicycle CPET from conventional pacing at 60 bpm to personalized physiologic pacing (myPACE), measured in mL/beat.
Arterial Elastance (Ea)
Change in arterial elastance (Ea), measured in mmHg/mL, calculated from echocardiographic measurements and non-invasive blood pressure measurements, from conventional pacing at 60 bpm at baseline to personalized physiologic pacing (myPACE) at 12 months.
End-Systolic Elastance (Ees)
Change in end-systolic elastance (Ees), measured in mmHg/mL, calculated from echocardiographic measurements and non-invasive blood pressure measurements, from conventional pacing at 60 bpm at baseline to personalized physiologic pacing (myPACE) at 12 months.
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