A Prospective and Randomized Controlled Trial of Empirical Formula of Traditinal Chinease Medicine in Treating Chronic Heart Failure

Not Applicable

• Conditions: Heart Failure

• Registration Number: ITMCTR2100005097
• Lead Sponsor: Chinese Academy of Medical Sciences Fuwai Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged 18 to 75 years;
2. Patients who meet the diagnostic criteria of Western medicine for coronary heart disease, elective patients within two weeks after DCB surgery;
3. Voluntary selection of patients who undergo coronary angiography 12 months after surgery;
4. Meet the TCM criteria for syndrome differentiation of Qi deficiency and blood stasis (total score >=8 points, and secondary symptoms >= 4 points);
5. The subjects voluntarily participated in the trial and signed the informed consent.

Exclusion Criteria

1. Heart valve disease, congenital heart disease, aortic dissection or aortic aneurysm requiring surgical or interventional treatment;
2. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, active myocarditis, infective endocarditis, constrictive pericarditis or other pericardial diseases;
3. Patients with malignant arrhythmia and poorly controlled hypertension;
4. Cardiac synchronization therapy within 3 months; cardiac PCI, CABG and other major vascular surgery or acute coronary syndrome within 1 month;
5. Cerebrovascular events such as old stroke and transient cerebral ischemia occurred within 6 months;
6. Patients with serious primary diseases and dysfunctions of the lung, liver, kidney, hematopoietic system, immune system, etc.;
7. Subjects who participated in other drug clinical trials or interventional studies within the first four weeks of this trial;
8. Patients with serious primary diseases and dysfunctions of the lung, liver, kidney, hematopoietic system, immune system, etc.;
9. Subjects who participated in other drug clinical trials or interventional studies within the first four weeks of this trial;
10. Those who are deemed unsuitable to participate in clinical trials by the investigator.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hospitalization for worsening heart failure;

Secondary Outcome Measures

Name	Time	Method
ew York Heart Association cardiac function;NT-proBNP;all-cause mortality;blood routine;left ventricular ejection fraction;Quantization Table for Traditional Chinese Medicine Syndrome Differentiation;Six-Minute Walk Distance;Minnesota heart failure quality of life scale;Hospital Anxiety and Depression Scale;hospitalization for cardiovascular events;