Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure
ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTasly Pharmaceutical Group Co., Ltd
About this trial
Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Jia Shen Tablet
DrugJia Shen Tablets contain 4 tablets (0.47 g per tablet), take orally, 2 times a day for 12 weeks
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Day 1,27-30,56,84.2
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 1,27-30,56,84.3
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.Secondary outcomes
1
NT-proBNP
Change from baseline to weeks 4,8 and 12 in NT-proBNP.
Time frame
Baseline to weeks 4,8 and 12.2
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 12.3
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.
Time frame
Baseline to weeks 12.4
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.Sponsors and contacts
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Source ClinicalTrials.gov