heart failure
Conditions
Interventions
Single arm:Oral traditional Chinese medicine
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80; 2. Clinically stable symptomatic heart failure with reduced ejection fraction, i.e.: a) Left ventricular ejection fraction (LVEF) = 40%; b) During the screening visit, patients with sinus rhythm should have an NT-proBNP level of =600 pg/mL, while patients with atrial fibrillation should have an NT-proBNP level of =900 pg/mL; c) NYHA heart function classification of II-III; d) Patients who have received pharmacotherapy (such as diuretics, ACE inhibitors, ARBs, ARNIs, beta blockers, MRAs, SGLT2 inhibitors) recommended by two or more guidelines, with a fixed dosage for more than one month, and whose condition remains stable; 3. Volunteer to sign the informed consent form before the commencement of activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to strictly adhere to the clinical trial protocol to complete this trial.
Exclusion criteria
Exclusion criteria: 1. Individuals who are known or suspected to be allergic to the known components of the trial drug; 2. Patients who have received traditional Chinese medicine treatment within 2 weeks; 3. Heart failure caused by special etiologies: arrhythmogenic cardiomyopathy, alcoholic cardiomyopathy, perinatal cardiomyopathy or cardiomyopathy caused by antineoplastic drugs, and heart failure caused by other toxic substances, endocrine or metabolic factors; 4. Heart failure with concurrent other diseases or conditions, including: a) Admission due to acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 4 weeks prior to the screening visit; b) Patients with significant mitral and/or aortic valve disease identified through hemodynamic examination require valve replacement or valvuloplasty; c) Symptoms of heart failure are primarily caused by other left ventricular outflow tract obstructive lesions with significant abnormalities in hemodynamic examination, including aortic stenosis and subaortic stenosis; d) Uncontrolled arrhythmia: untreated ventricular arrhythmia accompanied by syncope; symptomatic bradycardia such as second-degree or third-degree heart block without a pacemaker implanted; e) For patients with poorly controlled hypertension (systolic blood pressure =160mmHg and/or diastolic blood pressure =100mmHg), hypertension is confirmed after three measurements on different days; patients with symptomatic hypotension (systolic blood pressure 221 µM (2.5mg/dl) or eGFR <30 ml/min/1.73m2, as well as those with unstable or rapidly progressive kidney disease; 9. The value of bilirubin, AST, or ALT exceeds twice the upper limit of normal; 10. Patients with comorbid endocrine diseases, including: Type I diabetes, diabetic ketosis, and diabetic hyperosmolar coma; uncontrolled hyperthyroidism or hypothyroidism, except for patients who have received stable-dose thyroid hormone replacement therapy before screening and whose thyroid function tests (TSH/FT3/FT4) have reached the normal range; 11. Patients with other systemic diseases with an expected survival of less than 1 year, such as those with malignant tumors, severe primary hematological diseases, or other uncontrolled systemic diseases; 12. Patients who are pregnant, or women who plan to become pregnant within half a year, as well as breastfeeding women; 13. Screen for participants who have participated in other intervention-based clinical studies within the previous 30 days; 14.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NT-proBNP; | — |
Secondary
| Measure | Time frame |
|---|---|
| six-minute walk test?; echocardiogram ;Traditional Chinese Medicine Syndrome Score Scale;New York Heart Association functional class;Kansas City Cardiomyopathy Questionnaire;Cardiovascular death/heart failure worsening events;Adverse Drug Reaction and Serious Adverse Reaction; | — |
Countries
CHINA
Contacts
Public ContactZhang Ping
Beijing Tsinghua Changgung Hospital
Outcome results
None listed