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

Qualifiers

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

Treatments tested in this trial

  • Jia Shen Tablet

Treatment groups

18 Participants
are divided into 1 treatment group