Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

Brief Summary

Official Title: “Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease”

Patients with coronary artery disease have an abnormal cardiac metabolism. The hypothesis of this study is that shifting cardiac metabolism from free fatty acids to glucose will improve myocardial ischemia

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Detailed Clinical Trial Description

The present study will evaluate the effect of free fatty acid inhibition with Trimetazidine on silent myocardial ischemia and total ischemic burden in coronary artery disease patients with type II diabetes.

Patients will undergo ambulatory ECG monitoring at baseline and will be randomized to receive on top of thei standard anti-anginal therapy trimetazidine or placebo for 6 months. Patients will repeat the ambulatory ECG monitoring at the end of the study

Interventions Used in this Clinical Trial

  • Drug: Trimetazidine

Outcome Measures for this Clinical Trial

Primary Measures

  • total ischemic burden
  • silent ischemia

Secondary Measures

  • symptomatic myocardial ischemia

Criteria for Participation in this Clinical Trial

Inclusion Criteria

coronary artery disease type II diabetes mellitus

Exclusion Criteria

unstable coronary artery syndromes impaired liver and kidney function

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • IRCCS San Raffaele
  • Overall Official(s)
    • Giuseppe Marazzi, MD, Principal Investigator, H San Raffaele EUR


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