protocolSection identificationModule nctId: NCT06350487, orgStudyIdInfo id: SMC2024-01-089-003, briefTitle: The Efficacy of Enavogliflozin in Heart Failure With Preserved Ejection Fraction, acronym: ENRICH-PEF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, descriptionModule briefSummary: The aim of prospective, open label, single center, randomized controlled trial is to investigate the efficacy of enavogliflozin on exercise performance, diastolic dysfunction, and quality of life in patients with heart failure with preserved ejection fraction (HFpEF)., conditionsModule conditions: Heart Failure, Preserved Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective, open label, single center, randomized controlled trial., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 154, type: ESTIMATED, armsInterventionsModule interventions name: SGLT2 inhibitor, outcomesModule primaryOutcomes measure: Change in peak oxygen consumption (VO2), secondaryOutcomes measure: Change in minute ventilation to carbon dioxide output ratio (VE/VCO2 slope), secondaryOutcomes measure: Change in Left atrial volume index (LAVI) before and after maximal exercise, secondaryOutcomes measure: Change in Lateral Early diastolic transmitral filling velocity over early diastolic relaxation velocity at mitral annulus (E/e') before and after maximal exercise, secondaryOutcomes measure: Change in Left ventricular mass index (LVMI) before and after maximal exercise, secondaryOutcomes measure: Change in LV wall thickness before and after maximal exercise, secondaryOutcomes measure: Change in LV global longitudinal strain before and after maximal exercise, secondaryOutcomes measure: Change in LA strain before and after maximal exercise, secondaryOutcomes measure: Change in right ventricular (RV) free wall strain before and after maximal exercise, secondaryOutcomes measure: Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS), secondaryOutcomes measure: Change in N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) level, secondaryOutcomes measure: Change in chronotropic response reserve assessed by change in heart rate from rest to peak exercise, secondaryOutcomes measure: Change in serum iron, secondaryOutcomes measure: Change in ferritin, secondaryOutcomes measure: Change in total iron binding capacity, secondaryOutcomes measure: Change in hemoglobin, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Hospitalization for heart failure, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, city: Seoul, zip: 06351, country: Korea, Republic of, contacts name: Jeong Hoon Yang, MD, PhD, role: CONTACT, phone: 82-2-3410-3419, email: jhysmc@gmail.com, contacts name: David Hong, MD, role: CONTACT, phone: 82-2-3410-3419, email: hongdawi@naver.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False