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Based on accumulating evidence showing that impaired cardiac energetic metabolism plays important role in the mechanism of cardiac diastolic dysfunction,the study is designed to evaluate whether metabolic modulator treatment with trimetazidine could have beneficial effects on patients with coronary heart disease(CHD) and ventricular diastolic dysfunction.This study is a prospective,randomised,open-label trial to assess the efficacy of trimetazidine treatment in improving diastolic function in CHD patients with diastolic dysfunction.
The primary objective of this trial is to determine whether the 24-week trimetazidine therapy, as an adjunct to routine treatment for CHD, would improve diastolic function in patients with ischemic heart disease compared to the routine treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHD routine therapy | No Intervention | Patients with CHD will be treated with evidence-based therapy including antiplatelet drugs,beta-blockers,statins,angiotensin-converting enzyme inhibitor (ACEI),nitrates,etc. Percutaneous coronary intervention (PCI) could be performed if needed. | |
| CHD routine therapy+Trimetazidine | Experimental | Apart from the drug and PCI therapy mentioned above,patients will be given treatment of trimetazidine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimetazidine | Drug | Trimetazidine is given as 20mg every time and three times per day (Tid) or 20mg every time and two times per day (when renal function is declined). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage difference of patients with II or III degree diastolic dysfunction in each arm | II or III degree diastolic dysfunction is defined as average E/e' ratio more than 10 | Within 6 months after patients being enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Average E/e' ratio change between week 24 and baseline | Average e/e' is evaluated by ultracardiography | Within 6 months after patients being enrolled |
| E' velocity change of septum or of left ventricular lateral wall in m/s between week24 and baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Zhao | Contact | 008615810783328 | zhaoyanfuwai@163.com | |
| Kuo Zhang | Contact | 008618813019602 | kzhang23@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Zhao | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases | Beijing | Beijing Municipality | 100037 | China |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D014292 | Trimetazidine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
E' velocity change of septum or of left ventricular lateral wall is evaluated by ultracardiography
| Within 6 months after patients being enrolled |
| Velocity of tricuspid regurgitation change in m/s between week 24 and baseline | Velocity of tricuspid regurgitation is evaluated by ultracardiography | Within 6 months after patients being enrolled |
| Index of left atrium volume change between week 24 and baseline | Index of left atrium volume is evaluated by ultracardiography | Within 6 months after patients being enrolled |
| Concentration of the plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) change in pg/ml between week 24 and baseline | NT-proBNP is tested by Fuwai Hospital laboratory | Within 6 months after patients being enrolled |
| Number of participants with cardiovascular death and being rehospitalized for heart failure within 24 weeks treatment | This number will be acquired during follow up | Within 6 months after patients being enrolled |
| Concentration of glycated hemoglobin (HbA1c) change in patients with diabetes mellitus (DM) between week 24 and baseline | HbA1c (%)is tested by Fuwai Hospital laboratory | Within 6 months after patients being enrolled |