[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545120":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":71,"collaborators":25,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":25,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Guangdong Provincial Hospital of Traditional Chinese Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Qishen Granules","EXPERIMENTAL","On the basis of standardized drug treatment for HFpEF, participants who met the inclusion criteria were randomly given Qishen Granule intervention on the day of inclusion, taking it twice a day for 90 days.",[13],"Drug: Qishen Granules",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","On the basis of standardized drug treatment for HFpEF, participants who met the inclusion criteria were randomly given placebo granules on the day of inclusion, which were taken twice a day for 90 days (the placebo was basically the same as Qishen granules in terms of appearance, shape, color, taste, etc.)",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","One package per time, twice a day, 90 days of treatment",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"One package per time, twice a day, 90 days of treatment (the placebo was basically the same as Qishen granules in terms of appearance, shape, color, taste, etc.)",[15],[30],{"name":31,"affiliation":32,"role":33},"Lei Wang, doctorate","Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China","STUDY_DIRECTOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","8620-81887233-3280","Dr.wanglei@139.com",[40,58],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Guangdong Provincial Hospital of Chinese Medicine","RECRUITING","Guangzhou","Guangdong","510120","China","CN",{"type":49,"coordinates":50},"Point",[51,52],113.25,23.11667,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":57,"phoneExt":25,"email":38},"Lei Wang, M.D","8620-81887233-32801",{"facility":59,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"WangLei",{"type":49,"coordinates":61},[51,52],{"lat":52,"lon":51},[64,67],{"name":65,"role":36,"phone":66,"phoneExt":25,"email":38},"Lei \u002F Wang, doctorate","+8613724078381",{"name":68,"role":36,"phone":69,"phoneExt":25,"email":70},"Shuai \u002F Mao, doctorate","86-20-81887233-32801","maoshuaitcm@163.com",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Lei Wang,MD","Chief Physician","100545120","study-on-heart-failure-with-preserved-ejection-fraction-with-qishen-granules-100545120",false,"NCT06377761","Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules","A Randomized, Double-blind, Placebo-controlled Study on the Treatment of Heart Failure with Preserved Ejection Fraction with Qishen Granules Based on Cardiopulmonary Exercise Test","Inclusion Criteria:\n\n1. Sign the informed consent form\n2. Age 18-85 years old\n3. Heart failure was diagnosed ≥ 3 months before enrollment, The heart function classification II-IV of New York Heart Association (NYHA)\n4. has ≥ 1 of the following: 1） Structural heart disease (left atrial enlargement and\u002For left ventricular hypertrophy) recorded by echocardiography at the time of enrollment；2）Hospitalization due to heart failure within 12 months before enrollment\n5. Retention of ejection fraction: left ventricular ejection fraction (LVEF)≥50% (Echocardiography)\n6. Increase of NTpro-BNP (patients without atrial fibrillation\\>220pg\u002FmL, patients with atrial fibrillation\\>660pg\u002FmL\n7. If diuretics are being administered orally, the dose must be stable for ≥ 2 weeks before inclusion in the study\n8. At the time of randomization, it was clinically stable without signs of decompensation of cardiac failure (judged by the investigator)\n\nExclusion Criteria:\n\n1. Patients with decompensated heart failure\n2. Glomerular filtration rate (eGFR)\\\u003C30mL\u002Fmin\u002F1.73m 2\n3. Atrial fibrillation or atrial flutter with obvious liver disease or ALT, AST 3 times higher than the upper limit of normal\n4. Symptomatic hypotension or systolic blood pressure (SBP)\\\u003C100mmHg at the time of inclusion or baseline\n5. Resting heart rate recorded by echocardiography at the time of screening\\>110bpm\n6. Currently participating in another research equipment or drug test, or less than 30 days after the completion of another research equipment or drug test or receiving other research treatment. Patients participating in purely observational trials will not be excluded\n7. At present, people who are taking traditional Chinese medicine or Chinese patent medicine with similar effect to Qishen Granules\n8. Be allergic to any component of Qishen granules (astragalus membranaceus, salvia miltiorrhiza, and black aconite)\n9. Patients who refuse to sign the informed consent form or estimate poor compliance and women who are pregnant, nursing or planning to become pregnant during the trial","ALL","18 Years","85 Years",{"count":86,"type":87},80,"ESTIMATED","INTERVENTIONAL",[90],"NA","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.",[93],"Heart Failure with Preserved Ejection Fraction",[93,9,95],"Cardiopulmonary Exercise Test","2024-12-15",{"date":98,"type":99},"2024-12-18","ACTUAL",{"date":101,"type":99},"2023-05-01",{"date":103,"type":87},"2026-06-30",{"name":5,"class":6},2]