Status:
COMPLETED
A Phase IIa Clinical Trial on TSG-01 in the Treatment of Chronic Heart Failure in Patients With Coronary Heart Disease.
Lead Sponsor:
Shanghai Hongyitang Biopharmaceutical Technology Co. Ltd.
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief 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 fai...
Eligibility Criteria
Inclusion
- Age: 40 to 75 years.
- Have chronic heart failure(CHF) due to ischemic causes and defined as NYHA classification of III.
- Left ventricular ejection fraction (LVEF) of ≤45% and ≥25% as determined by improved biplane Simpson method
- NT-proBNP≥450pg/ml
- Be on a stable regime of standardized therapy for CHF at least 2 weeks prior to receiving study medication and are respected to remain on a stable regime throughout the duration of the trial without the need to receive intravenously vasoactive agents or/and diuretics. Standardized therapy includes ACEI/ARB, beta-blocker, aldosterone receptor antagonist, diuretic, digitalis.
- Is able to understand the trial and provide informed consent.
Exclusion
- Has hypertensive cardiopathy, pulmonary heart disease, congenital heart disease, moderate to severe pulmonary hypertension (pulmonary artery pressure ≥ 40mmHg), moderate to severe cardiac valve stenosis or insufficiency, any type of cardiomyopathy(hypertrophic, restrictive or dilated cardiomyopathy); moderate to severe pericardial effusion, constrictive pericarditis, and heart failure caused by arrhythmia.
- Has noncardiogenic heart failure caused by diseases in kidney, lung, liver, or by rheumatic immune disorders, severe infection and chemical factors (chemotherapy, alcohol, etc.).
- Has active tuberculosis or systemic lupus erythematosus (SLE)
- Had acute myocardial infarction, biventricular pacemaker implantation for cardiac resynchronization, cardiothoracic surgery or was complicated with acute coronary syndrome, pulmonary embolism and acute cerebrovascular disease within 3 months prior to receiving study medication.
- Had symptomatic ventricular tachycardia or pleomorphic ventricular tachycardia, cardiogenic shock (CGS), a progressive exacerbation of unstable angina, uncontrolled malignant arrhythmia, second degree sinoatrial or AV block Mobitz Type II or above without pacemaker implantation, QTc\>550 ms and heart rate \<50 bmp. Had uncontrolled hypertension, systolic blood pressure≥180/mmHg and/or diastolic blood pressure≥110mmHg, or hypotension with systolic blood pressure\<90mmHg and/or diastolic blood pressure\<60mmHg.
- Had coronary revascularization procedure (percutaneous or surgical) within 12 weeks prior to receiving study medication or be expected to have coronary revascularization or left ventricular remodeling operation in next 12 weeks.
- Has hepatic abnormality defined as ALT≥1.5 times the upper limit of normal, or has impaired renal function with Cr≥1.5 times the upper limit of normal. Has severe anemia (Hb\<70g/L), pheochromocytoma, hematopathy, gastrointestinal bleeding (consecutive fecal occult blood tests positive, except bleeding caused by hemorrhoids or other anal diseases).
- Has a body weight\>200kg.
- The subject has the need for mechanical ventilation, or has a history of a stroke or any malignancy within 4 weeks prior to receiving study medication.
- Has psychosis with poor control, or is a drug addict who has not been detoxified.
- Allergic to the study drug.
- Has participated in any clinical trial involving experimental therapy 3 months prior to screening.
- If female, being pregnant or lactating, or plan to get pregnant in next 3 months.
- Has a survival time less than 3 months according to the investigator's judgement.
- Subject who are taking Entresto (Sacubitril Valsartan Sodium Tablets) medication.
- Unable to complete the study or comply with the requirements of the study (for management or other reasons) according to the investigator's judgement.
Key Trial Info
Start Date :
May 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2022
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04515290
Start Date
May 7 2020
End Date
April 22 2022
Last Update
October 26 2022
Active Locations (5)
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1
Henan Province Hospital of TCM
Zhengzhou, Henan, China, 450000
2
The first Affiliated Hospital of Henan University of CM
Zhengzhou, Henan, China, 450000
3
Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China, 210029
4
Shanghai Shuguang Hospital
Shanghai, Shanghai Municipality, China, 200021