Efficacy and Safety of Jia Shen Tablets in Chronic Heart Failure

NCT ID: NCT06669169

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-12-31

Brief Summary

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo group

Group Type: PLACEBO_COMPARATOR

Jia Shen Tablet Placebo

Intervention Type: DRUG

Jia Shen Tablet Placebo contains 4 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks

Low dose group

Group Type: EXPERIMENTAL

Low dose Jia Shen Tablet

Intervention Type: DRUG

Low dose Jia Shen Tablet contains 2 tablets (0.47 g per tablet) and 2 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks

High dose group

Group Type: EXPERIMENTAL

High dose Jia Shen Tablet

Intervention Type: DRUG

High dose Jia Shen Tablet contains 4 tablets (0.47 g per tablet),take orally, 2 times a day for 12 weeks

Interventions

Jia Shen Tablet Placebo

Jia Shen Tablet Placebo contains 4 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks

Intervention Type: DRUG

Low dose Jia Shen Tablet

Low dose Jia Shen Tablet contains 2 tablets (0.47 g per tablet) and 2 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks

Intervention Type: DRUG

High dose Jia Shen Tablet

High dose Jia Shen Tablet contains 4 tablets (0.47 g per tablet),take orally, 2 times a day for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tasly Pharmaceutical Group Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Tianjin University of traditional Chinese

Tianjin, Tianjin Municipality, China

Countries

China

Central Contacts

Rui Liu

Role: CONTACT

liurui2@tasly.com

022-86343626

Facility Contacts

Jingyuan Mao

Role: primary

Other Identifiers

TSL-TCM-JSP-Ⅱ

Identifier Type: -

Identifier Source: org_study_id