A Open Label, Standardise-loaded and Single-Centre Phase Ⅰb Clinical Trial：Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetic characteristic evaluation：Maximum observed plasma concentration (Cmax)
研究概览
简要总结
Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment Group
Jia Shen Tablet，4 tablets，take orally，2 times a day
干预措施: Jia Shen Tablet (Drug)
结局指标
主要结局
Pharmacokinetic characteristic evaluation：Maximum observed plasma concentration (Cmax)
时间窗: Day 1,27-30,56,84.
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).
Plasma PK analysis: Time to reach peak or maximum observed concentration following drug administration (Tmax)
时间窗: Day 1,27-30,56,84.
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).
Plasma PK analysis: Area under curve at steady state (AUCss)
时间窗: Day 1,27-30,56,84.
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).
次要结局
- NT-proBNP(Baseline to weeks 4,8 and 12.)
- Echocardiogram results(Baseline to weeks 12.)
- AEs(From baseline (Day1) till follow-up visit (Up to 12 week).)
- 6-Minutes-Walking-Test (6MWT)(Baseline to weeks 4,8 and 12.)
- NYHA classification(Baseline to weeks 4,8 and 12.)