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Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease

W

Wuhan General Hospital of Guangzhou Military Command

Status and phase

Completed
Phase 4

Conditions

Left Ventriclar Mass

Treatments

Drug: Metformin
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01879293
2013Wze028

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups, including a placebo group

Metformin group
Experimental group
Description:
In this group, metformin 0.5 three times daily for one year.
Treatment:
Drug: Metformin
Placebo group
Placebo Comparator group
Description:
In this group, placebo will be given twice daily for one year.
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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