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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 â… b 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Jia Shen Tablet,4 tablets,take orally,2 times a day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jia Shen Tablet | Drug | Jia Shen Tablets contain 4 tablets (0.47 g per tablet), take orally, 2 times a day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | Day 1,27-30,56,84. |
| Measure | Description | Time Frame |
|---|---|---|
| NT-proBNP | Change from baseline to weeks 4,8 and 12 in NT-proBNP. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Liu | Contact | 022-86343626 | liurui2@tasly.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | Recruiting | Tianjin | Tianjin Municipality | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. | Baseline to weeks 12. |
| NYHA classification | Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 4,8 and 12. | Baseline to weeks 4,8 and 12. |
| AEs | Number of participants with adverse events (AEs). | From baseline (Day1) till follow-up visit (Up to 12 week). |