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Subclinical diastolic dysfunction represents the early phase of diabetic cardiomyopathy and is a common complication among type 2 diabetic patients that increases mortality rate among those patients and can progress to heart failure with preserved ejection fraction. Trimetazidine is an anti-ischemic agent widely used in the treatment of coronary artery disease and it has positive effects on energy metabolism in heart failure.
Therefore, we hypothesized that trimetazidine may have potential benefit on the amelioration of the inflammatory insult and improving the clinical outcomes in patients with diabetic cardiomyopathy especially if applied in the early stages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Patients will receive 35 mg of Trimetazidine modified release tablet twice daily in addition to their standard treatment for three months. |
|
| Group 2 | Placebo Comparator | Patients will receive Placebo tablet twice daily in addition to their standard treatment for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimetazidine Dihydrochloride | Drug | Trimetazidine Dihydrochloride 35 mg modified release tablet used twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Left ventricular functions at 3 months | assessed using echocardiographic and tissue doppler evaluation | at baseline and after three months of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Tumor necrosis factor alpha at 3 months | assessed using ELISA technique | at baseline and after three months of intervention |
| Change from baseline Transforming growth factor beta 1 at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| heba I serag, Master | Contact | 01008344689 | 002 | hebaibrahim92@pharm.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ainshams university hospitals | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39814796 | Derived | Serag H, Wakeel LE, William V, Abdelsalam M, Abdelsalam A, Sayed R. Effect of trimetazidine on left ventricular functions and cardiac biomarkers in diabetic patients with left ventricular diastolic dysfunction: a randomized controlled trial. Sci Rep. 2025 Jan 16;15(1):2115. doi: 10.1038/s41598-024-83213-w. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D058065 | Diabetic Cardiomyopathies |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System 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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| Placebo | Drug | Starch tablets used twice daily |
|
assessed using ELISA technique
| at baseline and after three months of intervention |
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |