Efficacy of Trimetazidine in Diabetic Patients

Ain Shams University

Status and phase: Enrolling; Phase 2

Conditions: Diabetic Cardiomyopathies; Diabetes Mellitus, Type 2

Treatments: Drug: Trimetazidine Dihydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05556005

RHDIRB2020110301

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Group 1

Experimental group

Description:

Patients will receive 35 mg of Trimetazidine modified release tablet twice daily in addition to their standard treatment for three months.

Treatment:

Drug: Trimetazidine Dihydrochloride

Group 2

Placebo Comparator group

Description:

Patients will receive Placebo tablet twice daily in addition to their standard treatment for three months.

Treatment:

Drug: Placebo