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PrEcision Pacing in HFpEF: the PEP-HFpEF Trial

9. November 2026 aktualisiert von: Tufts Medical Center

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

36

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: Individualized 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Peak Oxygen Consumption (Peak VO₂)
Zeitfenster: Baseline, 12 months

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.
Baseline, 12 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Ventilatory Efficiency (VE/VCO₂ Slope)
Zeitfenster: Baseline, 12 months

Change in the VE/VCO₂ slope during upright bicycle CPET from conventional pacing at 60 bpm to personalized physiologic pacing (myPACE).
Baseline, 12 months
Oxygen Pulse
Zeitfenster: Baseline, 12 months

Change in oxygen pulse during upright bicycle CPET from conventional pacing at 60 bpm to personalized physiologic pacing (myPACE), measured in mL/beat.
Baseline, 12 months
Arterial Elastance (Ea)
Zeitfenster: Baseline, 12 months

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.
Baseline, 12 months
End-Systolic Elastance (Ees)
Zeitfenster: Baseline, 12 months

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.
Baseline, 12 months
Ventriculo-Arterial Coupling (Ea/Ees Ratio)
Zeitfenster: Baseline, 12 months

Change in the Ea/Ees ratio, calculated from arterial elastance (Ea) and end-systolic elastance (Ees), from conventional pacing at 60 bpm at baseline to personalized physiologic pacing (myPACE) at 12 months.
Baseline, 12 months
Low-Frequency Blood Pressure Variability
Zeitfenster: Baseline, 12 months

Change in low-frequency blood-pressure variability during standardized autonomic nervous system testing from conventional pacing at 60 bpm at baseline to personalized physiologic pacing (myPACE) at 12 months.
Baseline, 12 months
Orthostatic Blood Pressure Recovery
Zeitfenster: Baseline, 12 months

Change in orthostatic blood pressure recovery during standardized autonomic nervous system testing from conventional pacing at 60 bpm at baseline to personalized physiologic pacing (myPACE) at 12 months.
Baseline, 12 months
Passive Leg Raise Response
Zeitfenster: Baseline, 12 months

Change in the passive-leg-raise response during standardized autonomic nervous system testing from conventional pacing at 60 bpm at baseline to personalized physiologic pacing (myPACE) at 12 months.
Baseline, 12 months
NTproBNP
Zeitfenster: Baseline, 6 months, 12 months, 15 months

NTproBNP level change from baseline to 12 months
Baseline, 6 months, 12 months, 15 months
Minnesota Living with Heart Failure Questionnaire Score
Zeitfenster: Baseline, 12 months

Change in total score on the Minnesota Living with Heart Failure Questionnaire (MLHFQ), a 21-item questionnaire assessing the impact of heart failure on health-related quality of life. The total score ranges from 0 to 105, with higher scores indicating worse health-related quality of life and greater impairment. Change in total score will be assessed from baseline to 12 months to evaluate the effect of personalized physiologic pacing compared with conventional pacing at 60 beats per minute.
Baseline, 12 months
Hospitalization or Invasive Outpatient Intervention for Heart Failure
Zeitfenster: Through 18 months

Throughout the duration of the study the study team will review intercurrent clinical management events that may occur as part of the natural history and clinical management of HFpEF, including hospitalization or invasive outpatient intervention for heart failure.
Through 18 months
Heart Failure Management Events
Zeitfenster: Through 18 months

Changes in heart failure management, including diuretic initiation, dose escalation, reduction, or discontinuation, and urgent medical visits for heart failure. Clinical events will be assessed through participant interviews and medical record review throughout study participation and formally assessed during each follow-up Assessment Window.
Through 18 months
Abnormal Heart Rhythm Management Events
Zeitfenster: Through 18 months

Throughout the duration of the study the study team will record changes in abnormal heart rhythm management, including initiation of antiarrhythmic medication, cardioversion, ablation, urgent medical visits for abnormal heart rhythms, or hospitalization for abnormal heart rhythms. Clinical events will be assessed through participant interviews and medical record review throughout study participation and formally assessed during each follow-up Assessment Window.
Through 18 months
Serious Cardiovascular Events
Zeitfenster: Through 18 months

Throughout the duration of the study the study team will review serious cardiovascular events, including heart attack, stroke, or death. Clinical events will be assessed through participant interviews and medical record review throughout study participation and formally assessed during each follow-up Assessment Window.
Through 18 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Tufts Medical Center

Ermittler

  • Hauptermittler: Margaret Infeld, MD, MS, Tufts Medical Center

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

1. März 2029

Studienabschluss (Geschätzt)

1. September 2029

Studienanmeldedaten

Zuerst eingereicht

14. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Oktober 2026

Zuerst gepostet (Tatsächlich)

8. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00007273: PEP-HFpEF
  • 26CDA1621876 (Andere Zuschuss-/Finanzierungsnummer: American Heart Association)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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