Clinical trial NCT01939236: Traditional Chinese Medicine for Treatment of Chronic Heart Failure
Official title: Traditional Chinese Medicine for Treatment of Chronic Heart Failure: A Multicenter Randomized Double-blind Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Heart Failure
Keywords: chronic heart failure
traditional Chinese medicine
syndrome differentiation
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Wuhan Hospital of Traditional Chinese Medicine
name: Zhengzhou Hospital of Traditional Chinese Medicine
name: Changchun University of Chinese Medicine
name: Hubei Hospital of Traditional Chinese Medicine
name: Yichang Hospital of Traditional Chinese Medicine
name: Dongzhimen Hospital, Beijing
name: Guang'an Men Hospital Affiliated to China Academy of Chinese Medicine Sciences
First posted: 2013-09-11
Enrollment: 220
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether traditional Chinese medicine as complementary treatment is safe and effective in the treatment of chronic heart failure.

Detailed description: Heart failure (HF) can be defined as an abnormality of cardiac structure or function leading to failure of heart to deliver oxygen at a rate commensurate with the requirements of the metabolizing tissues, despite normal filling pressures (or only at the expense of increased filling pressures). And according to the nature of the clinical presentation, HF is divided into acute or chronic HF.

In 2003, a random sample survey of 15,518 urban or rural residents between 35 and 74 years old was made in China: the prevalence rate of heart failure was 0.9%, and according to the result, there was about 4,000,000 HF subjects in China.

In China, the integrative treatment of western and traditional Chinese medicine (TCM) for HF is common and has been developed as a treatment model. TCM has been used in China and other south and east Asia countries for thousands of years. Syndrome differentiation and treatment variation are the basic principles in understanding and treatment of diseases. Investigators would like to test the hypothesis that it is efficacy and safety for patients to take TCM granules according to syndrome differentiation.

The specific aims for the study were to evaluate the efficacy and safety of TCM in treating chronic heart failure (CHF).

Eligibility criteria: Inclusion Criteria:

* The basic primary heart disease is coronary heart disease ( with diagnosis for coronary heart disease : confirmed by coronary angiography; confirmed by coronary CT; history of acute myocardial infarction; limb-salvage Q wave for ECG; ecg ECG test and radionuclide examination support, etc.); no history of hypertension or taking antihypertensive drugs, with blood pressure under 160/100 mmHg.
* With a history of coronary heart disease, symptoms and signs; with difficult breathing, fatigue and fluid retention (edema); with left ventricular enlargement, end systolic volume of left ventricular increase and left ventricular ejection fraction (LVEF) ≤ 40; with New York Heart Association (NYHA) functional classificationⅡ or Ⅲ.
* Male or female subjects between 40 and 75 years old;

Exclusion Criteria:

* Serious valvular heart disease, pericardial disease, cardiomyopathy, congenital heart disease, acute myocardial infarction ( within 4 weeks), cardiac shock, acute myocarditis or serious arrhythmia with the variation of hemodynamics.
* Pulmonary artery hypertension caused by pulmonary heart disease, acute or chronic pulmonary embolism, or stroke within a half year.
* Serious hepatic insufficiency ( the index of liver function being 2 times of normal one), renal insufficiency (Ccr\>20%, Scr\>3mg/dl or 265 μmol/L), diseases of blood system, malignant tumor, diabetes mellitus with serious complications, hyperthyroid or hypothyroid.
* Infection: fever; the numeration of leukocyte being more than 10×109/L, the percentage of neutrophile granulocyte being more than 85%; patchy shadows in X ray of Chest, meeting one of the above three.
* Pregnancy or lactation; mental disease and infectious disease patients.
* Take part in other trials within two months.

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 14 days, 28 days
Secondary outcomes:
measure: Traditional Chinese medicine syndrome scores (TCM-SS)
timeFrame: 14 days, 28 days
measure: New York Heart Association (NYHA) functional classification
timeFrame: 14 days, 28 days
measure: 6-minute walk test (6MWT)
timeFrame: 14 days, 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing University of Chinese Medicine
state: Beijing
Study officials:
affiliation: Beijing University of Chinese Medicine
name: Wei Wang, Doctor
role: STUDY_CHAIR
affiliation: Wuhan Hospital of Chinese Medicine
name: Peng Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing University of Chinese Medicine
name: Huihui Zhao, Doctor
role: STUDY_DIRECTOR
affiliation: Beijing University of Chinese Medicine
name: Liangtao Luo, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao K, Zhao H, Gao J, Wen B, Jia C, Wang Z, Zhang F, Wang J, Xie H, Wang J, Wang W, Chen J. Mechanism of Chinese Medicine Herbs Effects on Chronic Heart Failure Based on Metabolic Profiling. Front Pharmacol. 2017 Nov 22;8:864. doi: 10.3389/fphar.2017.00864. eCollection 2017.
citation: Luo L, Chen J, Guo S, Wang J, Gao K, Zhang P, Chen C, Zhao H, Wang W. Chinese Herbal Medicine in the Treatment of Chronic Heart Failure: Three-Stage Study Protocol for a Randomized Controlled Trial. Evid Based Complement Alternat Med. 2015;2015:927160. doi: 10.1155/2015/927160. Epub 2015 May 18.