Efficacy of Trimetazidine in Diabetic Patients

Ain Shams University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetes Mellitus, Type 2 Diabetic Cardiomyopathies

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline Left ventricular functions at 3 months

assessed using echocardiographic and tissue doppler evaluation

Time frame: at baseline and after three months of intervention

Secondary Outcomes

Change from baseline Tumor necrosis factor alpha at 3 months

assessed using ELISA technique

Time frame: at baseline and after three months of intervention

Change from baseline Transforming growth factor beta 1 at 3 months

assessed using ELISA technique

Time frame: at baseline and after three months of intervention

Efficacy of Trimetazidine in Diabetic Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts