Heart Failure reduced left ventricular ejection fraction
Conditions
Interventions
Metformin 500 mg 2dd1 or placebo 2dd1.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria are: - 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 6 hours before hospital admission, and an ECG recording with ST- segment elevation of more than 0.1 mV in 2 or more leads. - First myocardial infarction; - Successful primary PCI (TIMI 2/3); - At least one stent sized >= 3.0 mm; - Eligible for CMR imaging; - BMI
Exclusion criteria
Exclusion criteria: exclusion criteria are: - Rescue PCI after thrombolytic therapy; - Need for emergency coronary artery bypass grafting; - Inability to provide informed consent; - Younger than 18 years old; - Previous documented myocardial infarction; - Artificial breathing support; - Diabetes mellitus; - Algemene toestand van de patient die, op basis van de klinische inschatting van de behandeld arts en/of de onderzoeker, niet toestaat dat de patient deelneemt aan deze studie. General condition which, according to the clinical judgment of the investigator and/or treating physician, does not allow the patient to participate in the study - Contra-indication to metformin (see safety); - The existence of a life-threatening disease with a life-expectancy of less than 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the GIPS-III is to evaluate the efficacy of metformin treatment compared with placebo in adjunction to optimal reperfusion therapy for acute MI on left ventricular ejection fraction 4 months after randomisation as measured with CMR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study objectives include the investigation of the impact of metformin treatment on: - the incidence of a cardiovascular event within 4 months after randomization (all cause mortality, cardiovascular death, re myocardial infarction, reintervention (both re-PCI and CABG), stroke and combined endpoints); - the incidence of hospitalization for heart failure within 4 months; - the prevalence of new onset diabetes as defined by the current guidelines; - improving outcome as assessed by glycometabolic state (fasting blood glucose, HbA1c, insulin, GLP-1, HOMA-IR), inflammatory state (CRP, high-sensitivity CRP, TNF-alpha), lipid and cholesterol spectrum (LDL, HDL, total cholesterol, triglycerides), advanced glycation endproducts (AGEs), renal function (hemoglobin, hematocrit, MDRD), and neurohormones (NT pro-BNP, plasma renin activity, aldosterone) before hospital discharge and at each outpatient clinic visit. - Infarct size and TEI using LGE CMR imaging at 4 months follow-up. - Electrocardiographic determinants of myocardial perfusion (incidence of new Q waves, ST-segment resolution, persistent ST-deviation) before hospital discharge and at each outpatient clinic visit. - Body Mass Index (BMI) before hospital discharge and at each outpatient clinic visit. | — |
Countries
Netherlands
Outcome results
None listed