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OpenTrials
Completed

NCT Number: NCT01879293

Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wuhan General Hospital

Wuhan, Hubei, 430070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

Placebo

Drug

Primary outcomes

  1. Left ventricular mass.

    Time frame: one year

    We will measure left ventricular mass before and after metformin intervention with cardiac magnetic resonance.

Secondary outcomes

  1. Left ventricular volume and endothelial function.

    Time frame: one year

    We measure the left ventricular volume and endothelial function before and after metformin intervention by cardiac magnetic resonance and high resolution ultrasound.

Sponsors and collaborators

Lead sponsor

Wuhan General Hospital of Guangzhou Military Command

Other

Registry information

Official study title

Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease:A Randomized, Double-Blind, Placebo-Controlled Study

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 17, 2013
Registry last updated
Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.