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Metformin to Reduce Heart Failure After Myocardial Infarction (GIPS-III)

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ClinicalTrials.gov Identifier: NCT01217307
Recruitment Status : Unknown
Verified October 2013 by Chris Lexis, University Medical Centre Groningen.
Recruitment status was:  Active, not recruiting
First Posted : October 8, 2010
Last Update Posted : October 17, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction (STEMI) Coronary Artery Disease Heart Failure Diabetes Drug: Metformin Drug: Placebo Phase 2 Phase 3

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metabolic Modulation With Metformin to Reduce Heart Failure After Acute Myocardial Infarction: Glycometabolic Intervention as Adjunct to Primary Coronary Intervention in ST Elevation Myocardial Infarction (GIPS-III): a Randomized Controlled Trial.
Study Start Date : January 2011
Primary Completion Date : October 2013
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Metformin
metformin 500mg twice daily during 4 months
Drug: Metformin
Metformin 500mg twice daily during 4 months
Other Name: Glucophage
Placebo Comparator: Placebo
Placebo twice daily during 4 months
Drug: Placebo
Placebo twice daily during 4 months


Outcome Measures

Primary Outcome Measures :
  1. Improvement in left ventricular ejection fraction [ Time Frame: 4 months ]
    The primary efficacy parameter of the GIPS-III trial is LVEF measured by cardiac MRI 4 months after randomization, based on an intention-to-treat analysis. It is hypothesized that metformin therapy will result in a higher ejection fraction after 4 months.


Secondary Outcome Measures :
  1. the incidence of a cardiovascular event [ Time Frame: 4 months and longterm follow-up ]
    Cardiovascular events include major cardiac adverse events (MACE; death, recurrent MI, target lesion revascularization), stroke, non-elective hospitalizations for chest pain or heart failure, all recurrent coronary interventions, and internal cardiac defibrillator implantations. Mortality will be divided into cardiac and non-cardiac. Cardiac death will be divided into three categories: heart failure, sudden death and other. A cardiologist will confirm deaths from cardiovascular causes by examining medical records obtained from hospitals and attending physicians or from attending general practitioner if the patient died at home.

  2. markers of heart failure and glycometabolic state [ Time Frame: 4 months and longterm follow-up ]
    markers of heart failure: neurohormones (e.g. NT-proBNP), renal function (e.g. MDRD); glycometabolic state: e.g. HbA1c.

  3. Myocardial infarct size and transmural extent of infarction as measured with cardiac magnetic resonance imaging [ Time Frame: 4 months after hospitalization ]
    myocardial infarct size and transmural extent of infarction will be measured using Late Gadolinium Enhancement cardiac magnetic imaging

  4. diastolic function [ Time Frame: 4 months ]
    echocardiographic analysis of diastolic function

  5. glycometabolic state [ Time Frame: 4 months and long-term follow-up ]
    measured by oral glucose tolerance testing and Glycated Hemoglobin according to current criteria

  6. Cardiac MRI after 4 months, per protocol analysis [ Time Frame: 4 months ]
    A per-protocol analysis, excluding patients diagnosed with new onset diabetes and treated with oral antihyperglycemic agents or insulin prior to cardiac MRI, will be performed as a secondary efficacy parameter


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The diagnosis acute MI defined by chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 12 hours before hospital admission, and an ECG recording with ST- segment elevation of more than 0.1 mV 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 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 6 months.
Contacts and Locations

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): NCT01217307


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Center Groningen
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Iwan CC van der Horst, MD, PhD Thorax Centre, University Medical Centre Groningen
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chris Lexis, Drs., University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01217307     History of Changes
Other Study ID Numbers: GIPS-III 2010B257
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: October 17, 2013
Last Verified: October 2013

Keywords provided by Chris Lexis, University Medical Centre Groningen:
Metformin
ST elevation myocardial infarction (STEMI)
Coronary artery disease
Heart failure
Diabetes

Additional relevant MeSH terms:
Heart Failure
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
ST Elevation Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs