Clinical trial NCT06348498: Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Heart Failure
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pharmacokinetic characteristic evaluation：Maximum observed plasma concentration (Cmax)
timeFrame: Day 1,27-30,56,84.
measure: Plasma PK analysis: Time to reach peak or maximum observed concentration following drug administration (Tmax)
timeFrame: Day 1,27-30,56,84.
measure: Plasma PK analysis: Area under curve at steady state (AUCss)
timeFrame: Day 1,27-30,56,84.
Secondary outcomes:
measure: NT-proBNP
timeFrame: Baseline to weeks 4,8 and 12.
measure: 6-Minutes-Walking-Test (6MWT)
timeFrame: Baseline to weeks 4,8 and 12.
measure: Echocardiogram results
timeFrame: Baseline to weeks 12.
measure: NYHA classification
timeFrame: Baseline to weeks 4,8 and 12.
measure: AEs
timeFrame: From baseline (Day1) till follow-up visit (Up to 12 week).
Other outcomes:
Locations:
city: Tianjin
country: China
facility: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
Study officials:
References: