Chronic Heart Failure Clinical Trial
Official title:
A Phase IIa Clinical Trial on TSG-01 in the Treatment of Chronic Heart Failure in Patients With Coronary Heart Disease.
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03597646 -
The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure
|
N/A | |
| Terminated |
NCT04065997 -
Apogee International
|
||
| Withdrawn |
NCT03675113 -
Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure
|
N/A | |
| Completed |
NCT02916160 -
Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study
|
Phase 4 | |
| Completed |
NCT03126656 -
Effects of Testosterone on Myocardial Repolarization
|
Phase 4 | |
| Completed |
NCT02268500 -
VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)
|
Phase 4 | |
| Completed |
NCT02247245 -
The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients.
|
N/A | |
| Terminated |
NCT01906957 -
Cognition and Exercise Training
|
N/A | |
| Completed |
NCT01919918 -
Muscle Afferent Feedback Effects in Patients With Heart Failure
|
Phase 1 | |
| Not yet recruiting |
NCT01669395 -
Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial
|
N/A | |
| Completed |
NCT00984529 -
Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia
|
N/A | |
| Recruiting |
NCT00863421 -
Sleep Disordered Breathing in Patients With Chronic Heart Failure
|
N/A | |
| Completed |
NCT02840565 -
Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453
|
Phase 1 | |
| Completed |
NCT02441218 -
Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study
|
Phase 3 | |
| Completed |
NCT00149409 -
Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure
|
Phase 2/Phase 3 | |
| Terminated |
NCT05532046 -
A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)
|
Phase 1 | |
| Recruiting |
NCT04984928 -
Readmission Risk of Patients With Heart Failure.
|
||
| Completed |
NCT02814097 -
A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
|
Phase 2 | |
| Active, not recruiting |
NCT05560737 -
ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
|
||
| Recruiting |
NCT03286127 -
Palliative Outcome Evaluation Muenster I
|