Prospective Observational Study of Trimetazidine Influence on Mitochondrial Metabolism in Human Heart Ventricle
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|ClinicalTrials.gov Identifier: NCT02152527|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : May 28, 2015
|Condition or disease|
|Coronary Artery Disease|
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.
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|Observational Model:||Case Control|
|Official Title:||Myocardial Energetics as a Target for Treatment of Ischemic Heart Disease: A Translational Approach From Patient to Mitochondria|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Patients for coronary artery bypass grafting surgery who had preoperative trimetazidine usage in standard ischemic coronary disease therapy.
Patients for coronary artery bypass grafting surgery who had standard therapy for ischemic coronary disease without trimetazidine.
- Change in rate of myocardial oxygen consumption expressed in pmolO2/min/units of citrate synthase activity. [ Time Frame: Within 24 hours after tissue biopsy ]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.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152527
|School of Medicine, University of Split|
|Split, Croatia, 21000|
|Principal Investigator:||Marko Ljubković, M.D., PhD||Department of Physiology, University of Split School of Medicine|