Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Jia Shen Tablets contain 4 tablets (0.47 g per tablet), take orally, 2 times a day for 12 weeks
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
RECRUITINGPharmacokinetic 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).
Time frame: 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).
Time frame: 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).
Time frame: Day 1,27-30,56,84.
NT-proBNP
Change from baseline to weeks 4,8 and 12 in NT-proBNP.
Time frame: 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.
Time frame: 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.
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Time frame: Baseline to weeks 12.
NYHA classification
Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 4,8 and 12.
Time frame: Baseline to weeks 4,8 and 12.
AEs
Number of participants with adverse events (AEs).
Time frame: From baseline (Day1) till follow-up visit (Up to 12 week).