A Phase IIa Clinical Trial on TSG-01 in the Treatment of Chronic Heart Failure in Patients With Coronary Heart Disease.
Status:
Recruiting
Trial end date:
2022-05-07
Target enrollment:
Participant gender:
Summary
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.