Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease

Phase 4

Completed

• Conditions: Left Ventriclar Mass
• Interventions: Drug: placebo; Drug: Metformin

• Registration Number: NCT01879293
• Lead Sponsor: Wuhan General Hospital of Guangzhou Military Command

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-17
• Study Start: 2013-07
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-15
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	placebo	In this group, placebo will be given twice daily for one year.
Metformin group	Metformin	In this group, metformin 0.5 three times daily for one year.

Primary Outcome Measures

Name	Time	Method
Left ventricular mass.	one year	We will measure left ventricular mass before and after metformin intervention with cardiac magnetic resonance.

Secondary Outcome Measures

Name	Time	Method
Left ventricular volume and endothelial function.	one year	We measure the left ventricular volume and endothelial function before and after metformin intervention by cardiac magnetic resonance and high resolution ultrasound.

Trial Locations

Locations (1)

Wuhan General Hospital; 🇨🇳 Wuhan, Hubei, China