Efficacy of Trimetazidine in Diabetic Patients

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Trimetazidine

Criteria

Inclusion Criteria:

1. Age from 40-75 years

2. Patients with echocardiographic evidence of grade I or II diastolic dysfunction with LVEF ≥50%

Exclusion Criteria:

1. Patients with valvular, congenital or ischemic heart disease.

2. Patients with inadequately controlled hypertension (blood pressure>140/90 mm Hg)

3. Patients with HbA1c% <10 %

4. Patients with history of intolerance or allergic response to TMZ

5. Patients with severe liver dysfunction or severe renal dysfunction (creatinine clearance < 30 ml/min)

6. Patients with other significant comorbidities such as malignancy, significant psychiatric illness, autoimmune diseases.

7. Patients with Parkinson's disease or motor disorders

8. Pregnancy and breast feeding