Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure

NCT06348498 | Recruiting Phase 1

• 1 other identifier: TSL-TCM-JSP-Ⅰb
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• NT-proBNP

  Baseline to weeks 4,8 and 12.

• 6-Minutes-Walking-Test (6MWT)

  Baseline to weeks 4,8 and 12.

• Echocardiogram results

  Baseline to weeks 12.

• NYHA classification

  Baseline to weeks 4,8 and 12.

• AEs

  From baseline (Day1) till follow-up visit (Up to 12 week).

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Drug: Jia Shen Tablet

Interventions

Jia Shen Tablet DRUG

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

Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Rui Liu

CONTACT

022-86343626; liurui2@tasly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 4, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 28, 2024

Record last verified: 2024-03

Locations

CN (1)