protocolSection identificationModule nctId: NCT06377761, orgStudyIdInfo id: BF-2022-121, briefTitle: Study on Heart Failure With Preserved Ejection Fraction With Qishen Granules, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Guangdong Provincial Hospital of Traditional Chinese Medicine, class: OTHER, descriptionModule briefSummary: With the cardiopulmonary exercise testing as the primary outcome, the study aims to evaluate the efficacy of Qishen Granules on cardiac function, quality of life and biomarker level of patients with heart failure with preserved ejection fraction (HFpEF), which will provide evidence for the treatment of HFpEF with traditional Chinese medicine., conditionsModule conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Random parallel grouping, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Qishen Granules, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes in peak oxygen uptake within the average minute (PeakVO2) compared to baseline on day 90, secondaryOutcomes measure: Changes in Mitral valve diastolic blood flow velocity (E) and Mitral annulus lateral and septal motion velocity (e') compared to baseline on day 90, secondaryOutcomes measure: Changes in E/e' ratio compared to baseline on day 90, secondaryOutcomes measure: Changes in Left Atrial Volume index (LAVI) compared to baseline on day 90, secondaryOutcomes measure: Changes in Left ventricular mass index (LVMI) compared to baseline on day 90, secondaryOutcomes measure: Changes in Score of Kansas City Cardiomyopathy Questionnaire (KCCQ) compared to baseline on day 90, secondaryOutcomes measure: Changes in blood N terminal pro B type natriuretic peptide(NT-proBNP) compared to baseline on day 90, secondaryOutcomes measure: Changes in blood Growth STimulation expressed gene 2(ST2) compared to baseline on day 90, secondaryOutcomes measure: Changes in blood urea compared to baseline on day 90, secondaryOutcomes measure: Changes in blood creatinine compared to baseline on day 90, otherOutcomes measure: Changes in Aspartate aminotransferase(AST) compared to baseline on day 90, otherOutcomes measure: Changes in Alanine aminotransferase(ALT) compared to baseline on day 90, otherOutcomes measure: Number of participants with treatment-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Provincial Hospital of Chinese Medicine, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Lei Wang, M.D, role: CONTACT, phone: 8620-81887233-32801, email: Dr.wanglei@139.com, geoPoint lat: 23.11667, lon: 113.25, locations facility: WangLei, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Lei Wang, doctorate, role: CONTACT, phone: +8613724078381, email: Dr.wanglei@139.com, contacts name: Shuai Mao, doctorate, role: CONTACT, phone: 86-20-81887233-32801, email: maoshuaitcm@163.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False