Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure

A Open Label, Standardise-loaded and Single-Centre Phase Ⅰb Clinical Trial：Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure

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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Jia Shen Tablet

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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rui Liu; Phone Number: 022-86343626; Email: liurui2@tasly.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
      • Contact: Yuhong Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Jia Shen Tablet，4 tablets，take orally，2 times a day	Drug: Jia Shen Tablet; Jia Shen Tablets contain 4 tablets (0.47 g per tablet), take orally, 2 times a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic characteristic evaluation：Maximum observed plasma concentration (Cmax)	To characterize the multiple dose PK of Jia Shen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in patients with Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Deficiency with Blood Stasis).	Day 1,27-30,56,84.
Plasma PK analysis: Time to reach peak or maximum observed concentration following drug administration (Tmax)	To characterize the multiple dose PK of Jia Shen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in patients with Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Deficiency with Blood Stasis).	Day 1,27-30,56,84.
Plasma PK analysis: Area under curve at steady state (AUCss)	To characterize the multiple dose PK of Jia Shen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in patients with Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Deficiency with Blood Stasis).	Day 1,27-30,56,84.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NT-proBNP	Change from baseline to weeks 4,8 and 12 in NT-proBNP.	Baseline to weeks 4,8 and 12.
6-Minutes-Walking-Test (6MWT)	Change from baseline to weeks 4,8 and 12 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.	Baseline to weeks 4,8 and 12.
Echocardiogram results	Change from baseline to weeks 12 in left ventricular end diastolic diameter(LVEDD) measured by echocardiography. Change from baseline to weeks 12 in left ventricular end diastolic volume(LVEDV) measured by echocardiography. Change from baseline to weeks 12 in left ventricular end systolic volume(LVESV) measured by echocardiography. Change from baseline to weeks 12 in left ventricular ejection fraction(LVEF) measured by echocardiography. Change from baseline to weeks 12 in stroke volume(SV) measured by echocardiography. Change from baseline to weeks 12 in cardiac output(CO) measured by echocardiography.	Baseline to weeks 12.
NYHA classification	Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 4,8 and 12.	Baseline to weeks 4,8 and 12.
AEs	Number of participants with adverse events (AEs).	From baseline (Day1) till follow-up visit (Up to 12 week).

Collaborators and Investigators

• Sponsor: Tasly Pharmaceutical Group Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: TSL-TCM-JSP-Ⅰb

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No