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PrEcision Pacing in HFpEF: the PEP-HFpEF Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests personalized pacemaker heart rate settings, called myPACE, compared with standard settings. It is for adults with heart failure whose hearts still pump out a normal share of blood and who already have a certain type of pacemaker. The study will check effects on exercise ability, heart function, blood test results, quality of life, and health outcomes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have heart failure with preserved ejection fraction (HFpEF). This means you have heart failure signs and symptoms, but your heart pumps out at least 50% of the blood in its main pumping chamber.
  • You have symptoms with regular or light activity (NYHA Class II or III), even while taking stable doses of recommended medicines at the highest doses you can tolerate.
  • You already have an FDA-approved pacemaker that helps coordinate your heartbeat. It was placed for a standard medical reason and can have its lowest heart rate setting adjusted for you.
  • You are expected to need your pacemaker throughout the study.
  • Your health is stable, with no recent major heart failure changes that the study doctor thinks would affect the results.
  • You can and will give written consent to join.
  • You can and will complete all study steps and visits. These include pacemaker adjustments, exercise tests of your heart and lungs, heart ultrasound scans, blood pressure checks, blood draws, and tests of nerves that control automatic body functions.

Who can't join

  • You are younger than 18.
  • Your heart pumps out less than 50% of the blood in its main pumping chamber.
  • You are pregnant or breastfeeding, or you could become pregnant and will not use an accepted birth control method during the study.
  • You cannot or will not give consent to join.
  • The study doctor thinks you cannot safely complete the tests, including exercise or tests of nerves that control automatic body functions.
  • The study doctor thinks a health condition or your expected length of life would make the study unsafe or greatly affect your ability to finish it or the study results.
  • You are in another study testing a treatment that the study doctors think could affect this study or its results.
  • You are a prisoner, under the state's legal care, or otherwise not allowed to join under the rules or the study center's policies.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MA