Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2022-09-18
2023-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1
Patients will receive 35 mg of Trimetazidine modified release tablet twice daily in addition to their standard treatment for three months.
Trimetazidine Dihydrochloride
Trimetazidine Dihydrochloride 35 mg modified release tablet used twice daily
Group 2
Patients will receive Placebo tablet twice daily in addition to their standard treatment for three months.
Placebo
Starch tablets used twice daily
Interventions
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Trimetazidine Dihydrochloride
Trimetazidine Dihydrochloride 35 mg modified release tablet used twice daily
Placebo
Starch tablets used twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with echocardiographic evidence of grade I or II diastolic dysfunction with LVEF ≥50%
Exclusion Criteria
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
40 Years
75 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Heba ibrahim Mohamed serag
Assistant lecturer of clinical pharmacy- faculty of pharmacy
Locations
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Ainshams university hospitals
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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RHDIRB2020110301
Identifier Type: -
Identifier Source: org_study_id
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