Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease

NCT01879293 | Completed Phase 4 DMC

• 1 other identifier: 2013Wze028
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Metformin; Left ventricular mass; Endothelial dysfunction; cardiac magnetic resonance; aortic pulse wave

Outcome Measures

Primary Outcomes (1)

• Left ventricular mass.

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

  one year

Secondary Outcomes (1)

• Left ventricular volume and endothelial function.

  one year

Study Arms (2)

Metformin group

EXPERIMENTAL

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

Drug: Metformin

Placebo group

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Metformin DRUG

Metformin group

placebo DRUG

Placebo group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan General Hospital of Guangzhou Military Command: lead

Study Sites (1)

Wuhan General Hospital

Wuhan, Hubei, 430070, China

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endocrinol Dept.

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 17, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 18, 2015

Record last verified: 2015-08

Locations

CN (1)