Traditional Chinese Medicine for Treatment of Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

Traditional Chinese Medicine for Treatment of Chronic Heart Failure: A Multicenter Randomized Double-blind Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939236
• Other study ID #: BUCMlltllt1984
• Status: Completed
• Phase: Phase 2
• First received: August 13, 2013
• Last updated: October 8, 2013
• Start date: May 2010
• Est. completion date: September 2012

Study information

• Verified date: October 2013
• Source: Beijing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 classification? or ?.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• traditional Chinese medicine
1 bag of drug 2 times per day for 28 days according to syndrome differentiation. For example, the syndrome of one patient is qi deficiency and blood stasis, he will take drugs of qi deficiency and blood stasis each bag 2 times per day for 28days.
• Placebo (gummeline)
Placebo of each syndrome differentiation has the same weight and smell as traditional Chinese medicine of corresponding syndrome differentiation. 1 bag of drug 2 times per day for 28 days according to syndrome differentiation. For example, the syndrome of one patient is qi deficiency and blood stasis, he will take drugs of qi deficiency and blood stasis each bag 2 times per day for 28 days.

Locations

Country	Name	City	State
China	Beijing University of Chinese Medicine	Beijing	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine	Changchun University of Chinese Medicine, Dongzhimen Hospital, Beijing, Guang'an Men Hospital Affiliated to China Academy of Chinese Medicine Sciences, Hubei Hospital of Traditional Chinese Medicine, Wuhan Hospital of Traditional Chinese Medicine, Yichang Hospital of Traditional Chinese Medicine, Zhengzhou Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction	The level of left ventricular ejection fraction was detected with the modified Simpson's rule at baseline and 28 days.	14 days, 28 days	No
Secondary	Traditional Chinese medicine syndrome scores (TCM-SS)	Before the study, all investigators took standardized training and conformance testing. Syndrome differentiation and syndrome scores were took by 3 investigators together, and the results needed to obtain two or more investigators' consent. There were 65 clinical symptoms evaluated as TCM symptoms, which was defined as TCM syndrome score. The standard of TCM symptoms scored as without 0; very light 1; light 2; medium 3; heavy 4; very heavy 5 points.	14 days, 28 days	No
Secondary	New York Heart Association (NYHA) functional classification		14 days, 28 days	No
Secondary	6-minute walk test (6MWT)	6MWT was took according to the guidelines for the 6MWT promulgated by the American Thoracic Society at baseline and 28 days after treatment.	14 days, 28 days	No