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PrEcision Pacing in HFpEF: the PEP-HFpEF Trial

9 de novembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

36

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Peak Oxygen Consumption (Peak VO₂)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Ventilatory Efficiency (VE/VCO₂ Slope)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Tufts Medical Center

Investigadores

  • Investigador principal: Margaret Infeld, MD, MS, Tufts Medical Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de novembro de 2026

Conclusão Primária (Estimado)

1 de março de 2029

Conclusão do estudo (Estimado)

1 de setembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

14 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de outubro de 2026

Primeira postagem (Real)

8 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • STUDY00007273: PEP-HFpEF
  • 26CDA1621876 (Número de outro subsídio/financiamento: American Heart Association)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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