The purpose of this study is to assess the safety, efficacy and optimal dose of TSG-01, an innovative drug with ginsenosides as its main components, in the treatment of patients with chronic heart failure(CHF). Preclinical studies have revealed that TSG-01 promote myocardial energy metabolism and ATP production, reduce the damage of human pulmonary microvascular endothelial cell connection, resist arrhythmia, and regulate the lipid metabolism disorder caused by myocardial ischemia. Results from CHF animal models(dog, rat) showed that TSG-01 significantly increase coronary blood supply, improve myocardial contractility, reduce heart expansion and pulmonary edema. Besides its potency of improving heart function, TSG-01 was found to induce diuresis without obvious effect on urine potassium in rats. TSG-01 has been approved by CFDA for a clinical trial on the treatment of CHF (Approval No. 2018L03012). A randomized, double-blind, multicenter, placebo-controlled phase IIa clinical trial is now being conducted in 5 hospitals in China. A total of 90 cases of CHF caused by coronary heart disease are included and randomly divided into three groups: high-dose, low-dose of TSG-01 and placebo group. NYHA functional class, 6-minute walk test(6MHWT) distance, NT-proBNP, left ventricular ejection fraction(LVEF), echocardiographic parameters (LVESV, LVEDV, and heart size) and MLHFQ score are measured before, during and after treatment to evaluate the benefits of TSG-01 therapy in patients with CHF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
85
Two tablets of TSG-01 (0.35g/tablet) were given by oral with 3 times a day for 12 weeks; High dose group.
One tablet of TSG-01 (0.35g/tablet) and one tablet of placebo (0.35g/tablet) were given by oral with 3 times a day for 12 weeks; Low dose group.
Two tablets of placebo (0.35g/tablet) were given by oral with 3 times a day for 12 weeks.
Henan Province Hospital of TCM
Zhengzhou, Henan, China
The first Affiliated Hospital of Henan University of CM
Zhengzhou, Henan, China
Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China
Shanghai Shuguang Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, China
New York Heart Association (NYHA) Classification
Change from baseline and placebo in NYHA class status. NYHA Classification is a heart function classification which divides impaired cardiac function into four levels according to the action capacity of the patient. And among NYHA classification, Class I represents the mildest symptoms, while Class IV represents the most severe case.
Time frame: 12th week after intervention
Six(6)-minute walk test
To measure the distance that the patient is instructed to walk along a hallway as far as he(or she) can in 6 minutes.
Time frame: 12th week after intervention
Change of NT-proBNP (N-Terminal Pro-B-Type Natriuretic Peptide) Level from baseline and placebo
Time frame: 12th week after intervention
Change in LVEF from screening/baseline as determined by echocardiography
Time frame: 12th week after intervention
Change in LVESV from screening/baseline as determined by echocardiography
Time frame: 12th week after intervention
Change in LVEDV from screening/baseline as determined by echocardiography
Time frame: 12th week after intervention
Change in cardiac size from screening/baseline as determined by echocardiography
Time frame: 12th week after intervention
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: 12th week after intervention
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