Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will assess the efficacy and safety of QSG in CHF.

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

Details

• Lead Sponsor: Beijing University of Chinese Medicine
• Collaborators: Beijing Anzhen Hospital; China-Japan Friendship Hospital; Zhengzhou Hospital of Traditional Chinese Medicine

Criteria

Inclusion Criteria:

1. age between 18 and 75 years;

2. clinical findings of CHF for at least 3 months prior to screening;

3. CHF caused by coronary heart disease and hypertension, which is diagnosed according to the Chinese guidelines published in 2014 for the diagnosis and management of CHF;

4. clinically stable condition with an NYHA functional class of II to III and an optimal medical treatment with a fixed dosage for at least 2 weeks;

5. a documented left ventricular ejection fraction (LVEF) ≤40% and a serum NT-proBNP level ≥450 pg/ml;

6. CHF of Qi deficiency and blood stasis syndrome;

7. provision of written informed consent.

Exclusion Criteria:

1. CHF complicated with severe valvular disease, congenital heart disease, pericardial disease, cardiomyopathy, unstable angina, acute myocardial infarction(in recent 4 weeks), cardiogenic shock, acute myocarditis, infective endocarditis, uncontrolled severe cardiac arrhythmia with hemodynamic changes;

2. pulmonary heart disease, pulmonary hypertension caused by acute or chronic pulmonary embolism or cerebral apoplexy in recent 6 months;

3. severe hepatic inadequacy with alanine aminotransferase or alkaline phosphatase levels >2 times the upper normal limit, renal inadequacy with a creatinine clearance rate>20% or a serum creatinine level>3mg/dl (>265μmol/L), severe electrolyte imbalance, severe hematologic disease, malignant tumor, diabetes mellitus with severe complications, or severe endocrine diseases such as hyperthyroidism and hypothyroidism;

4. acute infection confirmed by any one of the following 3 tips: 1) fever; 2) a white blood cell count>10×109/L and a percentage of neutrophils>85%; 3) shadows on chest X-ray;

5. uncontrolled blood pressure or fibrosis in other organs;

6. CHF of yin deficiency according to TCM syndrome differentiation;

7. pregnancy or breastfeeding;

8. psychiatric or infectious disease;

9. patients who have participated in other clinical trials in the past two months.