Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease:A Randomized, Double-Blind, Placebo-Controlled Study|
- Left ventricular mass. [ Time Frame: one year ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]We measure the left ventricular volume and endothelial function before and after metformin intervention by cardiac magnetic resonance and high resolution ultrasound.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01879293
|Contact: Xiang Guangda, MD||+8602768878410||Guangda64@hotmail.com|
|Wuhan General Hospital||Recruiting|
|Wuhan, Hubei, China, 430070|
|Contact: Xiang Guangda, MD +8602768878410 Guangda64@hotmail.com|