Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease

This study is currently recruiting participants.
Verified June 2013 by Wuhan General Hospital of Guangzhou Military Command
Sponsor:
Information provided by (Responsible Party):
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT01879293
First received: June 11, 2013
Last updated: September 4, 2013
Last verified: June 2013

June 11, 2013
September 4, 2013
July 2013
December 2014   (final data collection date for primary outcome measure)
Left ventricular mass. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
We will measure left ventricular mass before and after metformin intervention with cardiac magnetic resonance.
Same as current
Complete list of historical versions of study NCT01879293 on ClinicalTrials.gov Archive Site
Left ventricular volume and endothelial function. [ Time Frame: one year ] [ Designated as safety issue: No ]
We measure the left ventricular volume and endothelial function before and after metformin intervention by cardiac magnetic resonance and high resolution ultrasound.
Same as current
Not Provided
Not Provided
 
Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease
Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease:A Randomized, Double-Blind, Placebo-Controlled Study

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Left Ventriclar Mass
  • Drug: Metformin
  • Drug: placebo
  • Experimental: Metformin group
    In this group, metformin 0.5 three times daily for one year.
    Intervention: Drug: Metformin
  • Placebo Comparator: Placebo group
    In this group, placebo will be given twice daily for one year.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
40 Years to 70 Years
No
Contact: Xiang Guangda, MD +8602768878410 Guangda64@hotmail.com
China
 
NCT01879293
2013Wze028
Yes
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
Wuhan General Hospital of Guangzhou Military Command
Not Provided
Not Provided
Wuhan General Hospital of Guangzhou Military Command
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP