Heart Failure with Preserved Ejection Fraction
Conditions
Interventions
intervention group:Gui Zhi Wu Ling Wan combined with standardized Western medicine treatment
Control group:Gui Zhi Wu Ling Wan placebo combined with standardized Western medicine treatment
Sponsors
Chongqing Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Aged 18–75 years, with no restriction on sex; (2)After a 1-week run-in period, patients meet the diagnostic criteria for HFpEF; (3)Meet the Traditional Chinese Medicine (TCM) syndrome differentiation criteria for Yang deficiency, blood stasis, and water retention; (4)NYHA functional class II–III; Provide written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1)Heart failure caused by other cardiac or systemic diseases, including but not limited to congenital heart disease, primary pulmonary arterial hypertension, cardiomyopathy, valvular heart disease, rheumatic diseases, and autoimmune diseases; (2)Concomitant severe primary hepatic, renal, or hematologic diseases, or severe psychiatric disorders or other uncontrolled systemic diseases. For patients with renal dysfunction: serum creatinine >194.5 µmol/L or serum potassium >5.5 mmol/L; For patients with hepatic dysfunction: alanine aminotransferase (ALT) or alkaline phosphatase (ALP) >1.5 times the upper limit of normal (ULN); (3)Presence of left ventricular outflow tract obstruction, myocarditis, aortic aneurysm, aortic dissection, or unrepaired valvular heart disease causing significant hemodynamic changes; Presence of cardiogenic shock, refractory malignant arrhythmias, sinoatrial or atrioventricular block of second-degree type II or higher without pacemaker implantation, progressively worsening unstable angina, or acute myocardial infarction; (4)Planned coronary revascularization or cardiac resynchronization therapy (CRT) in the near future, or patients who have already undergone CRT; (5)Uncontrolled hypertension, defined as systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg; or hypotension, defined as systolic blood pressure <90 mmHg and/or diastolic blood pressure <60 mmHg; (6)Allergic constitution or known allergy to the study medication; (7)Pregnant or lactating women; (8)Participation in other clinical trials within the past 3–6 months, or use of medications with similar therapeutic effects or active ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NT-ProBNP; | — |
Secondary
| Measure | Time frame |
|---|---|
| left ventricular internal diameter in diastole,LVIDd;left ventricular internal diameter in systole,LVIDs;left ventricular posterior wall thickness in diastole,LVPWd;fractional shortening,FS;Left ventricular ejection fraction,LVEF;6-minute walk test;peak oxygen uptake,Peak VO2;anaerobic threshold,AT;minute ventilation-to-carbon dioxide output slope,VE/VCO2slope;Soluble Growth-Stimulating Expressed Gene 2 Protein,sST2;Galectin-3,Gal-3;Growth Differentiation Factor 15 ,GDF-15;Type I Collagen ,COL1;Type III Collagen ,COL3;Cardiac Fibronectin,Fn;a-Smooth Muscle Actin,a-SMA;New York Heart Association (NYHA) Functional Classification;Traditional Chinese Medicine Syndrome Grading;Minnesota Heart Failure Quality of Life Questionnaire;Free fatty acids,FFA;circumferential end-systolic stress,cESS;Myocardial energy expenditure,MEE;Major Adverse Cardiovascular Events; | — |
Countries
China
Contacts
Public ContactWangchenghu
Chongqing Traditional Chinese Medicine Hospital
Outcome results
None listed