Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease

Study Overview
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Brief Summary
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Cardiovascular disease is the most common cause of death in the world. Most of the attention in treating ischemic heart disease (IHD) is understandably directed toward treating coronary artery disease. However there are other treatable culprits in these patients. Left ventricular hypertrophy (LVH) is widespread in IHD patients, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality than either multivessel cor-onary disease or impaired LV function. Metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes. In the UKPDS (United Kingdom Prospective Diabetes Study), metformin was associated with a 39% lower risk of myocardial infarction compared with conventional therapy. Metformin also offered dual benefits of improving vascular function and lessening ischemia in nondiabetic patients. Hence, the main aim of this study was to assess whether metformin could regress LVM in patients with IHD. The secondary aim was to assess the effect of metformin on LV volumes and endothelial function in this patient group.

Official Title
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Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease:A Randomized, Double-Blind, Placebo-Controlled Study

Conditions
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Left Ventriclar Mass

Intervention / Treatment
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* Drug: Metformin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They had to have normal glucose tolerance. They had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction. They were required to have an office BP < 130/80 mm Hg The presence of LVH on echocardiography (American Society of Echocardiography criteria LVM index [LVMI] > 115 g/m2 for men and > 95 g/m2 for women). Exclusion Criteria: They were currently prescribed metformin. They had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent. Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin group<br>In this group, metformin 0.5 three times daily for one year. | Drug: Metformin<br> <br> |
| Placebo Comparator: Placebo group<br>In this group, placebo will be given twice daily for one year. | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular mass. | We will measure left ventricular mass before and after metformin intervention with cardiac magnetic resonance. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular volume and endothelial function. | We measure the left ventricular volume and endothelial function before and after metformin intervention by cardiac magnetic resonance and high resolution ultrasound. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metformin, Left ventricular mass, Endothelial dysfunction, cardiac magnetic resonance, aortic pulse wave