Heart Failure with Preserved Ejection Fraction (HFpEF)
Conditions
Interventions
Test group:Standard therapy plus Fuzheng Yangxin Granules
Control group:Standard therapy plus Fuzheng Yangxin Granules placebo
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1)Aged between 18 and 80 years, regardless of sex; (2)Diagnosed with Qi and Yin deficiency accompanied by blood stasis according to traditional Chinese medicine (TCM) syndrome differentiation; (3)Meet the diagnostic criteria for heart failure with preserved ejection fraction (HFpEF) as defined in the 2023 National Guidelines for the Diagnosis and Treatment of Heart Failure; 1)Epidemiological and demographic features consistent with HFpEF; 2)Symptoms and/or signs of heart failure, such as dyspnoea, reduced exercise tolerance, and oedema; 3)Left ventricular ejection fraction (LVEF) =50% on echocardiography; 4)Objective evidence of cardiac structural and/or functional abnormalities consistent with left ventricular diastolic dysfunction and/or elevated left ventricular filling pressure, including: (i) a ratio of early diastolic transmitral flow velocity to early diastolic mitral annular velocity (E/e') >15; (ii) septal e' 2.8 m/s or estimated pulmonary artery systolic pressure (PASP) >35 mmHg; (iv) increased left atrial volume index (LAVI), defined as LAVI >34 mL/m² in patients with sinus rhythm or >40 mL/m² in patients with atrial fibrillation; and (v) elevated natriuretic peptide (NP) levels. (4)Willing and able to provide written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1)Diagnosis of cardiac infiltrative diseases (e.g., cardiac amyloidosis), storage diseases (e.g., hemochromatosis, Fabry disease), reversible cardiomyopathies (e.g., stress-induced cardiomyopathy), hypertrophic obstructive cardiomyopathy, constrictive pericarditis, muscular dystrophy, or severe valvular heart disease; (2)Stroke or transient ischemic attack diagnosed within the past 3 months, or having undergone coronary artery bypass grafting, aortic valve replacement, or other major cardiovascular surgery; (3)Pulmonary diseases that limit exercise capacity or may interfere with exercise interventions; (4)Pregnancy, current breastfeeding, or planning pregnancy during the study period; (5)Severe diseases affecting the clinical course, including acute exacerbation of chronic obstructive pulmonary disease, acute or chronic liver disease, severe renal impairment, anemia, gastrointestinal surgeries or diseases that may affect drug absorption, acute or chronic pancreatitis, severe primary hematologic or psychiatric disorders, or any documented active or suspected malignancy within the past year; (6)Any disease other than heart failure that, in the investigator's judgment, is expected to limit life expectancy to less than 6 months; (7)Allergy-prone individuals, those with multiple drug or food allergies, or known allergy to any component of Fuzheng Yangxin Granules; (8)Patients unable to exercise, or judged by investigators to have impaired mobility, inability to perform daily living activities independently, or inability to take oral medications; (9)Receiving any investigational treatment other than the study drug; (10)History or suspicion of alcohol or substance abuse; (11)Inability to comply with study follow-up schedule or deemed unsuitable for trial participation by the investigator's clinical judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of composite cardiovascular outcomes, including cardiovascular death and heart failure rehospitalization; | — |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D score;Kansas City Cardiomyopathy Questionnaire (KCCQ) ;6-minute walk test (6MWT);Echocardiography;N-terminal pro–B-type natriuretic peptide (NT-proBNP);Traditional Chinese Medicine (TCM) Syndrome Score;New York Heart Association (NYHA) functional class;Peak Oxygen Uptake ; | — |
Countries
China
Contacts
Public ContactLongtao Liu
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed