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

Myocardial Energetics as a Target for Treatment of Ischemic Heart Disease: A Translational Approach From Patient to Mitochondria

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02152527
Enrollment
55
Registered
2014-06-02
Start date
2014-01-31
Completion date
2015-04-30
Last updated
2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief 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.

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.

Interventions

None listed

Sponsors

University of Split, School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in rate of myocardial oxygen consumption expressed in pmolO2/min/units of citrate synthase activity.Within 24 hours after tissue biopsyInvestigators 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.

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026