Metformin to Reduce Heart Failure After Myocardial Infarction

Last updated: July 31, 2017
Sponsor: University Medical Center Groningen
Overall Status: Completed

Phase

2/3

Condition

Coronary Artery Disease

Diabetic Vitreous Hemorrhage

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT01217307
GIPS-III 2010B257
  • Ages > 18
  • All Genders

Study Summary

The investigators will evaluate the effect of metformin therapy during 4 months in non-diabetic patients following ST-elevation myocardial infarction on left ventricular ejection fraction as measured with cardiac magnetic resonance imaging, compared to placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The diagnosis acute MI defined by chest pain suggestive for myocardial ischemia for atleast 30 minutes, the time from onset of the symptoms less than 12 hours beforehospital admission, and an ECG recording with ST- segment elevation of more than 0.1mV in 2 or more leads.

  • Successful primary PCI (post-procedural TIMI 2/3);

  • At least one stent sized ≥ 3.0 mm;

  • Eligible for 3T CMR imaging;

  • Verbal followed by written informed consent.

Exclusion

Exclusion Criteria:

  • rescue PCI after thrombolytic therapy;

  • need for emergency coronary artery bypass grafting;

  • creatinin >177 μmol/L measured pre-PCI;

  • Younger than 18 years;

  • Mechanical ventilation;

  • Diabetes;

  • Prior myocardial infarction;

  • Contra-indication to metformin (see safety);

  • The existence of a life-threatening disease with a life-expectancy of less than 6months.

Study Design

Total Participants: 380
Study Start date:
January 01, 2011
Estimated Completion Date:
October 31, 2015

Study Description

In this trial, the investigators will evaluate the effect of metformin therapy following ST-elevation myocardial infarction (STEMI) in a total of 380 non-diabetic patients. This trial is a randomized, double blind, controlled trial. The intervention, which consist of metformin 500mg twice daily or placebo twice daily, will commence within three hours after the percutaneous coronary intervention, and will be continued for 4 months. The primary endpoint is the difference between the two intervention groups (metformin vs placebo) in left ventricular ejection fraction, as measured with magnetic resonance imaging after 4 months. The investigators hypothesize that metformin therapy results in a significantly higher ejection fraction in this population.

Connect with a study center

  • University Medical Center Groningen

    Groningen, 9700RB
    Netherlands

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.