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CompletedNCT02152527Updated May 28, 2015

Prospective Observational Study of Trimetazidine Influence on Mitochondrial Metabolism in Human Heart Ventricle

An observational study in Coronary Artery Disease, sponsored by University of Split, School of Medicine. Completed at 1 site in Croatia. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-05-28.

Sponsored by University of Split, School of Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
55
Ages
30 Years to 80 Years
Sex
All
01

Study summary

Trimetazidine (1-[2,3,4-trimethoxybenzyl] piperazine dihydrochloride) is a clinically effective antianginal agent. Despite these clinical successes, the understanding of trimetazidine's mechanism of action remains incomplete, particularly influence of trimetazidine on mitochondrial function in isolated human cardiomyocytes. The investigators will perform this study to seek possible differences in mitochondrial respiration related to standard preoperative enrolled trimetazidine therapy.

Read the detailed description

Background:

Different types of medication are used for treatment of ischemic heart disease. One of recently developed drugs is trimetazidine. Although it clinical benefits are clear, mechanism by which this occurs is as yet undefined. In few animal studies authors try to define what effects trimetazidine has on both fatty acid and glucose metabolism in heart. Data collected from human cardiomyocytes are rare. Available data suggest that trimetazidine may act as a potent inhibitor of beta oxidation, with no significant effect on glucose oxidation.

Objective:

Primary objective: collection of mitochondrial respiration data using human heart ventricular samples. Secondary objective: define possible differences in mitochondrial respiration depending on preoperative trimetazidine usage.

Methods:

Regularly scheduled patients for coronary artery bypass grafting surgery who accept to participate in study will be enrolled in further protocol. Patients with inclusion criteria and without exclusion criteria will be enrolled in the study. At the end of operation, surgeon will take biopsy sample of left ventricle for mitochondrial function and metabolic activity analysis.

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Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 55 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University of Split, School of Medicine is the lead sponsor of 49 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with coronary artery disease planned for coronary artery bypass grafting

Inclusion criteria

  • Patients with coronary artery disease who are candidates for coronary artery bypass graft (CABG) surgery.

Exclusion criteria

Exclusion Criteria:

  • Emergency patients, patients who already had heart surgery, patients with acute coronary syndrome in last 2 months, patients with inability to understand patient information and informed consent.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
55 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Trimetazidine

    Patients for coronary artery bypass grafting surgery who had preoperative trimetazidine usage in standard ischemic coronary disease therapy.

  • Control

    Patients for coronary artery bypass grafting surgery who had standard therapy for ischemic coronary disease without trimetazidine.

06

What researchers measure

Primary outcomes

  1. Change in rate of myocardial oxygen consumption expressed in pmolO2/min/units of citrate synthase activity.

    Investigators will obtain left ventricular biopsy samples from patients suffering from ischemic heart disease. Samples will be prepared in the laboratory for the purpose of assessment of mitochondrial respiration. Using the specific substrates from either fatty acid or carbohydrate metabolic pathways will enable investigation of the effect of trimetazidine on cardiac tissue metabolism.

    Time frame: Within 24 hours after tissue biopsy

07

Study locations

1 site
  • School of Medicine, University of Split
    Split, 21000, Croatia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02152527
Lead sponsor
University of Split, School of Medicine
Responsible party
Marko Ljubkovic (associate professor, M.D., PhD, University of Split, School of Medicine) — Principal investigator
First posted
Jun 2, 2014
Start date
Jan 2014
Primary completion
Apr 2015
Completion
Apr 2015
Last update
May 28, 2015

Study contacts

Marko Ljubković, M.D., PhD
principal investigator · Department of Physiology, University of Split School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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