Heart Failure with Preserved Ejection Fraction (HFpEF)
Conditions
Interventions
Experimental Group:Western medicine standardized treatment + Shengxian Yixin granules
Control Group:Standardized Western medical treatment + Shengxian Yixin granule simulator
Sponsors
Henan University of Traditional Chinese Medicine First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: (1) Age 18-75 years, any gender; (2) Meets diagnostic criteria for coronary heart disease; (3) LVEF =50% by echocardiography; (4) NT-proBNP =125 pg/ml (=365 pg/ml for atrial fibrillation patients); (5) Meets TCM syndrome differentiation criteria for Qi Deficiency and Blood Stasis; (6) Willing to sign informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: (1) Hypertrophic obstructive cardiomyopathy, cardiac amyloidosis, hemochromatosis, Fabry disease, stress cardiomyopathy, constrictive pericarditis, muscular dystrophy, or severe valvular heart disease; (2) Stroke/TIA within 3 months, or CABG/valve replacement/major cardiovascular surgery; (3) Pulmonary diseases limiting exercise (FEV1 <50% predicted, COPD GOLD III-IV); (4) Pregnancy, lactation, or planning pregnancy; (5) Severe comorbidities: acute COPD exacerbation, hepatic dysfunction (ALT =3×ULN), renal impairment (Cr =3 mg/dL or eGFR =30 ml/min/1.73m²), anemia (Hb <90 g/L), gastrointestinal disorders affecting drug absorption, active malignancies within 1 year; (6) Life expectancy <6 months per investigator; (7) Allergy to study drug components; (8) Physical/mental inability to exercise or comply with protocol; (9) Use of similar TCM preparations within 7 days; (10) Participation in other clinical trials; (11) Substance abuse history; (12) Investigator-determined ineligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiopulmonary Exercise Test Peak Oxygen Uptake (Peak VO2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Qi Deficiency and Blood Stasis Syndrome Score;Major Symptoms/Signs;Echocardiography;Cardiopulmonary Function;N-terminal pro-B-type natriuretic peptide;Coagulation function; | — |
Countries
China
Contacts
Public ContactWang Xinlu
Henan University of Traditional Chinese Medicine First Affiliated Hospital
Outcome results
None listed