[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659495":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":58,"studyPopulation":58,"armGroups":65,"interventions":72,"overallOfficials":78,"centralContacts":82,"locations":88,"responsibleParty":106,"collaborators":58,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":58,"eligibilityCriteria":113,"healthyVolunteers":110,"sex":114,"minAge":115,"maxAge":58,"enrollmentInfo":116,"targetDuration":58,"studyType":119,"phases":120,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":132,"whyStopped":58,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Tufts Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":58},[9],{"measure":10,"description":11,"timeFrame":12},"Peak Oxygen Consumption (Peak VO₂)","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\u002Fkg\u002Fmin.","Baseline, 12 months",[14,17,20,23,26,29,32,35,38,42,45,49,52,55],{"measure":15,"description":16,"timeFrame":12},"Ventilatory Efficiency (VE\u002FVCO₂ Slope)","Change in the VE\u002FVCO₂ slope during upright bicycle CPET from conventional pacing at 60 bpm to personalized physiologic pacing (myPACE).",{"measure":18,"description":19,"timeFrame":12},"Oxygen Pulse","Change in oxygen pulse during upright bicycle CPET from conventional pacing at 60 bpm to personalized physiologic pacing (myPACE), measured in mL\u002Fbeat.",{"measure":21,"description":22,"timeFrame":12},"Arterial Elastance (Ea)","Change in arterial elastance (Ea), measured in mmHg\u002FmL, 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.",{"measure":24,"description":25,"timeFrame":12},"End-Systolic Elastance (Ees)","Change in end-systolic elastance (Ees), measured in mmHg\u002FmL, 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.",{"measure":27,"description":28,"timeFrame":12},"Ventriculo-Arterial Coupling (Ea\u002FEes Ratio)","Change in the Ea\u002FEes 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.",{"measure":30,"description":31,"timeFrame":12},"Low-Frequency Blood Pressure Variability","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.",{"measure":33,"description":34,"timeFrame":12},"Orthostatic Blood Pressure Recovery","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.",{"measure":36,"description":37,"timeFrame":12},"Passive Leg Raise Response","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.",{"measure":39,"description":40,"timeFrame":41},"NTproBNP","NTproBNP level change from baseline to 12 months","Baseline, 6 months, 12 months, 15 months",{"measure":43,"description":44,"timeFrame":12},"Minnesota Living with Heart Failure Questionnaire Score","Change in MLHFQ total score from conventional pacing at 60 bpm to personalized physiologic pacing (myPACE).",{"measure":46,"description":47,"timeFrame":48},"Hospitalization or Invasive Outpatient Intervention for Heart Failure","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",{"measure":50,"description":51,"timeFrame":48},"Heart Failure Management Events","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.",{"measure":53,"description":54,"timeFrame":48},"Abnormal Heart Rhythm Management Events","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.",{"measure":56,"description":57,"timeFrame":48},"Serious Cardiovascular Events","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.",null,{"allocation":60,"interventionModel":61,"interventionModelDescription":58,"primaryPurpose":62,"observationalModel":58,"timePerspective":58,"maskingInfo":63},"NA","SINGLE_GROUP","TREATMENT",{"masking":64,"maskingDescription":58,"whoMasked":58},"NONE",[66],{"label":67,"type":68,"description":69,"interventionNames":70},"Individualized myPACE Pacing","EXPERIMENTAL","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.",[71],"Device: Individualized myPACE pacemaker programming",[73],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":58},"DEVICE","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.",[67],[79],{"name":80,"affiliation":5,"role":81},"Margaret Infeld, MD, MS","PRINCIPAL_INVESTIGATOR",[83],{"name":84,"role":85,"phone":86,"phoneExt":58,"email":87},"Courtney Uek","CONTACT","617-636-4354","courtney.uek@tuftsmedicine.org",[89],{"facility":5,"status":58,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Boston","Massachusetts","02111","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-71.05977,42.35843,{"lat":99,"lon":98},[102,103,105],{"name":84,"role":85,"phone":86,"phoneExt":58,"email":87},{"name":58,"role":85,"phone":58,"phoneExt":58,"email":104},"Margaret.Infeld@tuftsmedicine.org",{"name":80,"role":81,"phone":58,"phoneExt":58,"email":58},{"type":107,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR","100659495","precision-pacing-in-hfpef-the-pep-hfpef-trial-100659495",false,"NCT07864558","PrEcision Pacing in HFpEF: the PEP-HFpEF Trial","Inclusion Criteria:\n\n* Age ≥18 years.\n* 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.\n* New York Heart Association (NYHA) Class II or III symptoms despite stable, maximally tolerated guideline-directed medical therapy.\n* 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.\n* Expected to require ongoing pacemaker therapy throughout the study period.\n* 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.\n* Able and willing to provide written informed consent.\n* 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.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* Left ventricular ejection fraction \\\u003C50%.\n* Pregnancy, breastfeeding, or women of childbearing potential unwilling to use an acceptable method of contraception during study participation.\n* Inability or unwillingness to provide informed consent.\n* Inability to safely perform study procedures, including CPET or autonomic testing, in the opinion of the investigator.\n* 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.\n* Enrollment in another interventional clinical trial that, in the opinion of the investigators, could interfere with this study or confound interpretation of the results.\n* Prisoners, wards of the state, or other individuals for whom participation would not be permissible under applicable regulations or institutional policy.","ALL","18 Years",{"count":117,"type":118},36,"ESTIMATED","INTERVENTIONAL",[60],"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.",[123,124,125],"Heart Failure and Preserved Ejection Fraction","Heart Failure New York Heart Association Class III","Heart Failure New York Heart Association (NYHA) Class II",[127,128,129,130,131],"HFpEF","Heart Failure","pacemaker","personalized pacing","heart failure with preserved ejection fraction","NOT_YET_RECRUITING","2026-10-02",{"date":135,"type":136},"2026-10-08","ACTUAL",{"date":138,"type":118},"2026-10",{"date":140,"type":118},"2029-09",{"name":5,"class":6},1]