Suspended

Trimetazidine for Improved Left Ventricular Functions and Reduced Inflammation in Type 2 Diabetes Mellitus Patients

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Study Aim

This study aims to evaluate the effectiveness of Trimetazidine in improving left ventricular heart functions and reducing inflammation in individuals with Type 2 Diabetes Mellitus, measured through echocardiographic and tissue doppler evaluation after 3 months of treatment.

What is being tested

Trimetazidine Dihydrochloride

+ Placebo

Drug
Who is being recruted

Cardiovascular Diseases+8

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

From 40 to 75 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: September 2022
See protocol details

Summary

Principal SponsorAin Shams University
Study Contactheba I serag, Master
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 18, 2022

Actual date on which the first participant was enrolled.

This study focuses on patients with type 2 diabetes mellitus who often experience a common complication known as subclinical diastolic dysfunction. This condition is an early phase of diabetic cardiomyopathy, which can increase mortality rates and potentially lead to heart failure. The study aims to investigate the effects of Trimetazidine, a drug typically used to treat coronary artery disease, on this specific condition. Trimetazidine is known for its positive effects on energy metabolism in heart failure, and the hypothesis is that it may improve clinical outcomes for patients with diabetic cardiomyopathy, especially when applied in the early stages. During this phase 2 treatment study, participants will receive Trimetazidine. The study's primary outcome is to measure changes in left ventricular functions from the baseline after 3 months of treatment. These changes will be assessed using echocardiographic and tissue doppler evaluation, which are non-invasive methods to monitor heart function. The study aims to understand if Trimetazidine can improve heart health in patients with type 2 diabetes mellitus and subclinical diastolic dysfunction.

Official TitleEffect Of Trimetazidine On Left Ventricular Functions and Inflammatory Markers of Patients With Type 2 Diabetes Mellitus
NCT05556005
Principal SponsorAin Shams University
Study Contactheba I serag, Master
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHeart DiseasesMetabolic DiseasesCardiomyopathiesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes ComplicationsDiabetic Cardiomyopathies

Criteria

2 inclusion criteria required to participate
Age from 40-75 years

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

8 exclusion criteria prevent from participating
Patients with valvular, congenital or ischemic heart disease.

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

Patients with HbA1c% <10 %

Patients with history of intolerance or allergic response to TMZ

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Ainshams university hospitals

Cairo, EgyptOpen Ainshams university hospitals in Google Maps
SuspendedOne Study Center