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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
Sponsor:
Information provided by (Responsible Party):
Marko Ljubkovic, University of Split, School of Medicine

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.

Condition or disease
Coronary Artery Disease

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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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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
Parts of human left ventricular muscle


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with coronary artery disease planned for coronary artery bypass grafting
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152527


Locations
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Croatia
School of Medicine, University of Split
Split, Croatia, 21000
Sponsors and Collaborators
University of Split, School of Medicine
Investigators
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Principal Investigator: Marko Ljubković, M.D., PhD Department of Physiology, University of Split School of Medicine

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Responsible Party: Marko Ljubkovic, associate professor, M.D., PhD, University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT02152527     History of Changes
Other Study ID Numbers: TMZHHV
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Trimetazidine
Vasodilator Agents