NCT05556005

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

September 21, 2022

Last Update Submit

September 26, 2022

Conditions

Diabetes Mellitus, Type 2Diabetic Cardiomyopathies

Keywords

TrimetazidineDiastolic dysfunctiondiabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from baseline Tumor necrosis factor alpha at 3 months

    at baseline and after three months of intervention

  • Change from baseline Transforming growth factor beta 1 at 3 months

    at baseline and after three months of intervention

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: Trimetazidine Dihydrochloride

Group 2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Trimetazidine DihydrochlorideDRUG

Trimetazidine Dihydrochloride 35 mg modified release tablet used twice daily

Also known as: Vasteral mr
Group 1
PlaceboDRUG

Starch tablets used twice daily

Group 2

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 40-75 years
  • Patients with echocardiographic evidence of grade I or II diastolic dysfunction with LVEF ≥50%

You may not qualify if:

  • 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
  • Patients with severe liver dysfunction or severe renal dysfunction (creatinine clearance \< 30 ml/min)
  • Patients with other significant comorbidities such as malignancy, significant psychiatric illness, autoimmune diseases.
  • Patients with Parkinson's disease or motor disorders
  • Pregnancy and breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ainshams university hospitals

Cairo, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39814796DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetic CardiomyopathiesDiabetes Mellitus

Interventions

Trimetazidine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCardiomyopathiesHeart DiseasesCardiovascular DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

heba I serag, Master

CONTACT

01008344689hebaibrahim92@pharm.asu.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of clinical pharmacy- faculty of pharmacy

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 27, 2022

Study Start

September 18, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 27, 2022

Record last verified: 2022-09

Locations

EG(1)