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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05556005
Other study ID # RHDIRB2020110301
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 18, 2022
Est. completion date September 2023

Study information

Verified date September 2022
Source Ain Shams University
Contact heba I serag, Master
Phone 01008344689
Email hebaibrahim92@pharm.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
Trimetazidine Dihydrochloride
Trimetazidine Dihydrochloride 35 mg modified release tablet used twice daily
Placebo
Starch tablets used twice daily

Locations

Country Name City State
Egypt Ainshams university hospitals Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline Left ventricular functions at 3 months assessed using echocardiographic and tissue doppler evaluation at baseline and after three months of intervention
Secondary Change from baseline Tumor necrosis factor alpha at 3 months assessed using ELISA technique at baseline and after three months of intervention
Secondary Change from baseline Transforming growth factor beta 1 at 3 months assessed using ELISA technique at baseline and after three months of intervention
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