Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06348498
• Other study ID #: TSL-TCM-JSP-?b
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 31, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Tasly Pharmaceutical Group Co., Ltd
• Contact: Rui Liu
• Phone: 022-86343626
• Email: liurui2[@]tasly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 I? 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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceutical Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	NT-proBNP	Change from baseline to weeks 4,8 and 12 in NT-proBNP.	Baseline to weeks 4,8 and 12.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	AEs	Number of participants with adverse events (AEs).	From baseline (Day1) till follow-up visit (Up to 12 week).