Traditional Chinese Medicine for Treatment of Chronic Heart Failure

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing University of Chinese Medicine
• Collaborators: 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

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.