Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease
|ClinicalTrials.gov Identifier: NCT01879293|
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : August 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Left Ventriclar Mass||Drug: Metformin Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease:A Randomized, Double-Blind, Placebo-Controlled Study|
|Study Start Date :||July 2013|
|Primary Completion Date :||August 2015|
|Study Completion Date :||August 2015|
Experimental: Metformin group
In this group, metformin 0.5 three times daily for one year.
Placebo Comparator: Placebo group
In this group, placebo will be given twice daily for one year.
- Left ventricular mass. [ Time Frame: one year ]We will measure left ventricular mass before and after metformin intervention with cardiac magnetic resonance.
- Left ventricular volume and endothelial function. [ Time Frame: one year ]We measure the left ventricular volume and endothelial function before and after metformin intervention by cardiac magnetic resonance and high resolution ultrasound.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879293
|Wuhan General Hospital|
|Wuhan, Hubei, China, 430070|