Left Ventriclar Mass Clinical Trial
Official title:
Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease:A Randomized, Double-Blind, Placebo-Controlled Study
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 70 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| China | Wuhan General Hospital | Wuhan | Hubei |
| Lead Sponsor | Collaborator |
|---|---|
| Wuhan General Hospital of Guangzhou Military Command |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Left ventricular mass. | We will measure left ventricular mass before and after metformin intervention with cardiac magnetic resonance. | one year | Yes |
| Secondary | 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 | No |