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Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease

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ClinicalTrials.gov Identifier: NCT01879293
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : August 18, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Left Ventriclar Mass Drug: Metformin Drug: placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease:A Randomized, Double-Blind, Placebo-Controlled Study
Study Start Date : July 2013
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Left ventricular mass. [ Time Frame: one year ]
    We will measure left ventricular mass before and after metformin intervention with cardiac magnetic resonance.

Secondary Outcome Measures :
  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.

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879293

China, Hubei
Wuhan General Hospital
Wuhan, Hubei, China, 430070
Sponsors and Collaborators
Wuhan General Hospital of Guangzhou Military Command
More Information

Responsible Party: Xiang Guang-da, Director of Endocrinol Dept., Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT01879293     History of Changes
Other Study ID Numbers: 2013Wze028
First Posted: June 17, 2013    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015

Keywords provided by Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command:
Left ventricular mass
Endothelial dysfunction
cardiac magnetic resonance
aortic pulse wave

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Hypoglycemic Agents
Physiological Effects of Drugs