Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease

NCT ID: NCT01879293

Last Updated: 2015-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-08-31

Brief Summary

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.

Conditions

Left Ventriclar Mass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Metformin group

In this group, metformin 0.5 three times daily for one year.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Placebo group

In this group, placebo will be given twice daily for one year.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Metformin

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan General Hospital of Guangzhou Military Command

OTHER

Sponsor Role: lead

Responsible Party

Xiang Guang-da

Director of Endocrinol Dept.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wuhan General Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

2013Wze028

Identifier Type: -

Identifier Source: org_study_id