Heart failure
Conditions
Interventions
Xinli Granules intervention group:Standard therapy plus Xinli Granules
Xinli Granules placebo intervention group:Standard therapy plus Xinli Granules placebo
Sponsors
Guangdong Provincial Hospital of Chinese Medicine / Second Clinical Medical College, Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18–80 years, any sex. (2) Meets the HFpEF diagnostic criteria in the 2024 Chinese Guidelines for the Diagnosis and Treatment of Heart Failure and the 2023 Chinese Expert Consensus on the Diagnosis and Treatment of Heart Failure with Preserved Ejection Fraction: a. Presence of signs and/or symptoms of heart failure; b. Left ventricular ejection fraction (LVEF) = 50 % on echocardiography; c. At least one of the following: 1) Elevated NT-proBNP (=125 ng/L in sinus rhythm or =365 ng/L in atrial fibrillation); 2) E/e' = 15; d. In patients highly suspected clinically but not confirmed by routine transthoracic echocardiography and natriuretic peptide testing, perform stress echocardiography or invasive hemodynamic assessment; HFpEF is considered if any of the following is met: 1) Stress echocardiography shows E/e' = 15; 2) Resting right heart catheterization shows pulmonary capillary wedge pressure (PCWP) = 15 mmHg or left ventricular end-diastolic pressure (LVEDP) = 16 mmHg; 3) Exercise right heart catheterization shows peak-exercise PCWP = 25 mmHg. (3) NYHA class II–III. (4) Serum NT-proBNP = 450 pg/mL (non-atrial fibrillation) or =1 300 pg/mL (atrial fibrillation). (5) Not receiving or has discontinued any Chinese herbal medicines or Chinese patent medicines for cardiovascular disease at enrollment. (6) Willing to participate in the trial, has understood the information, and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Acute heart failure or acute decompensation of chronic heart failure. (2) Prior echocardiography showing left ventricular ejection fraction (LVEF) 2 mg/dL (176.82 µmol/L) or serum potassium > 5.5 mmol/L; hepatic transaminases or alkaline phosphatase > 3× upper limit of normal; active malignancy; severe neuro-endocrine or psychiatric disease; or any rapidly progressive illness judged by the investigator to have an expected survival < 1 year. (5) Left ventricular outflow tract obstruction, myocarditis, large-artery aneurysm, dissecting aneurysm, unrepaired valvular disease with significant hemodynamic compromise, cardiogenic shock, uncontrollable malignant arrhythmias, untreated second-degree type II or higher sinoatrial/AV block, unstable angina or acute myocardial infarction that is worsening. (6) Scheduled coronary revascularization or cardiac resynchronization therapy (CRT) within the near term, or prior CRT implantation. (7) Uncontrolled hypertension (systolic = 180 mmHg and/or diastolic = 110 mmHg), or hypotension (systolic < 80 mmHg and/or diastolic < 50 mmHg); HbA1c = 9.0 % or fasting plasma glucose = 13.9 mmol/L. (8) Known hypersensitivity or history of allergic reactions to any study medication. (9) Participation in another investigational drug trial within the past month. (10) Pregnant, planning pregnancy, or breastfeeding women. (11) Failure to meet inclusion criteria, refusal to sign the informed consent form, or any condition judged by the investigator to preclude completion of or compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NT-proBNP; | — |
Secondary
| Measure | Time frame |
|---|---|
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) score;New York Heart Association (NYHA) functional class;6-Minute Walk Test (6MWT);Traditional Chinese Medicine (TCM) Syndrome Score;Composite endpoint events (including hospitalization for worsening heart failure, all-cause mortality, and other major cardiovascular events);Echocardiographic parameters;E/e';Diuretic dosage;Hemorheology;hs-CRP;Coagulation parameters;Glycolipid metabolism parameters;Cardiopulmonary Exercise Testing (CPET) and Exercise Stress Echocardiography; | — |
Countries
China
Contacts
Public ContactLvWeihui
The Second Clinical Medical College, Guangzhou University of Chinese MedicineProvincial Laboratory of Traditional Chinese Medicine
Outcome results
None listed