Efficacy and Safety of Jia Shen Tablets in Chronic Heart Failure

Tasly Pharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Heart Failure

Treatments: Drug: Low dose Jia Shen Tablet; Drug: Jia Shen Tablet Placebo; Drug: High dose Jia Shen Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06669169

TSL-TCM-JSP-Ⅱ

Details and patient eligibility

About

Evaluate the efficacy and safety of Jia Shen Tablets in patients with Chronic Heart Failure.

Enrollment: 288 estimated patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 40-79 years, either sex;
• Meet the diagnostic criteria for CHD and CHF;
• Meet the TCM differentiation criteria of yang qi deficiency and blood stasis in CHF;
• Class Ⅱ to Ⅲ for NYHA functional classification;
• Willing to provide written informed consent.

Exclusion criteria

• CHF with acute exacerbation or intravenous drug therapy;
• Received cardiac resynchronization therapy (CRT) or other heart failure devices;
• Within 3 months before randomization, acute coronary syndrome（ACS）, stroke or transient ischemic attack（TIA） occurred or received cardiac revascularization (PCI, CABG);
• Plan to undergo cardiac revascularization (PCI, CABG) or cardiac resynchronization therapy (CRT) during the trial period;
• Severe arrhythmias [such as persistent atrial fibrillation, permanent atrial fibrillation, ventricular tachycardia, second-degree type II or higher sinus or atrioventricular block without pacemaker placement, QT interval (QTc) exceeding 480 ms after heart rate adjustment according to Fridericia's formula, or known history or symptoms of long QT syndrome];
• Severe hypertension (systolic blood pressure ≥180mm Hg or diastolic blood pressure ≥110mm Hg) or hypotension (systolic blood pressure < 90 mmHg);
• Heart failure caused by other cardiovascular diseases such as congenital heart disease, severe stenosis or insufficiency of heart valves, cardiomyopathy (e.g. hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate pericardial effusion, constrictive pericarditis, and infective endocarditis;
• Combined with liver, kidney, hematopoietic system and other serious primary diseases, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3 times the upper limit of local laboratory normal value, the estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2, Blood potassium > 5.5 mmol/L or hemoglobin (Hb) < 90 g/L; Malignant tumors, severe neuroendocrine system diseases and mental diseases;
• Pregnant or lactating;
• Participating in other interventional clinical studies within 1 month before screening;
• Allergic constitution, or allergic to Chinese medicines of Jia Shen Tablets (such as Periploca sepium, salvia miltiorrhiza, etc.);
• The investigator determines that the patient is unable to complete the study or comply with the requirements of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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288 participants in 3 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Treatment:

Drug: Jia Shen Tablet Placebo

Low dose group

Experimental group

Treatment:

Drug: Low dose Jia Shen Tablet

High dose group

Experimental group

Treatment:

Drug: High dose Jia Shen Tablet