PEP-HFpEF

Personalized Pacing in Heart Failure with Preserved Ejection Fraction: the PEP-HFpEF Trial

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Heart failure
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All genders
person-wave 18+
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Overview
Principal Investigator: Margaret Infeld, MD, MS

Researchers at Tufts Medical Center are studying whether personalized programming of an existing pacemaker using the myPACE pacing program can improve symptoms, exercise capacity, heart function, and quality of life in people with heart failure with preserved ejection fraction (HFpEF).

This study uses participants' existing FDA-approved physiologic pacemakers. No new pacemaker will be implanted as part of this research.

Participation lasts approximately 18 months.

Study details
Inclusion Criteria
  • Diagnosis of heart failure with preserved ejection fraction (HFpEF)
  • Existing physiologic permanent pacemaker
  • New York Heart Association (NYHA) Class II or III heart failure symptoms
Exclusion Criteria
  • Age <18 years
  • 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.
Study Requirements

Participants will complete a screening visit and four study assessment windows over approximately 18 months.

Study procedures include:
- pacemaker programming using the myPACE pacing program
- echocardiograms
- blood draws
- cardiopulmonary exercise testing (CPET)
- blood pressure and autonomic function testing
- questionnaires about heart failure symptoms and quality of life

Whenever possible, study procedures will be coordinated with routine pacemaker clinic visits.