PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Tufts Medical Center
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceIndividualized 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.
Location
- Tufts Medical CenterBoston, Massachusetts