Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure

NCT ID: NCT06348498

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-09
• Study Completion Date: 2026-06-30

Brief Summary

Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure.

Detailed Description

Jia Shen Tablets are oral, compound traditional chinese medicine. This open label, standardise-loaded and single-Centre phase Ⅰb clinical trial will evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in treatment of coronary heart disease complicating chronic heart failure (syndrome of Yang deficiency with blood stasis) and preliminarily evaluate the efficacy and safety.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Jia Shen Tablet，4 tablets，take orally，2 times a day

Group Type: EXPERIMENTAL

Jia Shen Tablet

Intervention Type: DRUG

Jia Shen Tablets contain 4 tablets (0.47 g per tablet), take orally, 2 times a day for 12 weeks

Interventions

Jia Shen Tablet

Jia Shen Tablets contain 4 tablets (0.47 g per tablet), take orally, 2 times a day for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18-75 years, either sex;
• Meet the diagnostic criteria for CHD and CHF;
• Meet the TCM differentiation criteria of yang deficiency and blood stasis in CHF;
• LVEF < 40% (Modified Simpson's Method);
• Class II to IⅢ for NYHA functional classification;
• Receive Steady dose of standard medication for CHF for at least 2 weeks;
• Understand the research requirements and are willing to provide written informed consent.

Exclusion Criteria

• Acute heart failure or acute exacerbation of chronic heart failure;
• HF caused by other heart 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 massive pericardial effusion, constrictive pericarditis, infective endocarditis;
• Patients with acute coronary syndrome within 30 days before receiving the trial drug，and the following situation within 6 months before receiving the trial drug，such as acute myocardial infarction，revascularization (e.g., PCI, CABG) or left ventricular reconstruction surgery, pacemaker implantation for cardiac resynchronization, and undergoing cardiothoracic surgery;
• Expect to receive an implantable device (e.g. ICD, CRT), or revascularization (e.g. PCI, CABG), or other cardiovascular surgery during the trial period;
• Severe arrhythmias [e.g., ventricular tachycardia, second degree type II or higher sinus or atrioventricular block without pacemaker placement, QT interval (QTc) greater than 480 ms after heart rate adjustment according to Fridericia's formula, or known history or symptoms of long QT syndrome];
• Combined with serious diseases of other systems, such as liver, kidney, hematopoietic system and other serious primary diseases, tumors, mental diseases, etc;
• The presence of uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg), or the presence of hypotension (systolic blood pressure < 80 mmHg and/or diastolic blood pressure < 50 mmHg);
• ALT or AST more than 3 times the upper limit of normal, and/or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2;
• Glycosylated hemoglobin (HbA1c) ≥9.0%, or fasting blood glucose ≥13.9 mmol/L;
• Anemia (Hb < 110 g/L for women, Hb < 120 g/L for men);
• Blood potassium is above the upper limit of normal;
• Patients who tested positive for five hepatitis B tests (except surface antibodies) or hepatitis C, or anti-TP or HIV antibodies;
• Patients with a history of drug abuse who test positive for drug abuse (morphine, methamphetamine, ketamine, dimethyldioxyamphetamine, THC, cocaine);
• Women who are pregnant or nursing, or have a need to have children within 3 months after the last dose of the trial;
• Participating in other studies and taking investigational drugs from other studies within 3 months prior to screening;
• Allergic to Jiashen tablets or their ingredients;
• Other situations judged by the researchers to be inappropriate for this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 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 Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rui Liu

Role: CONTACT

liurui2@tasly.com

022-86343626

Facility Contacts

Yuhong Huang

Role: primary

Other Identifiers

TSL-TCM-JSP-Ⅰb

Identifier Type: -

Identifier Source: org_study_id