Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention Phase
Left Ventriclar Mass
Drug: Metformin
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease:A Randomized, Double-Blind, Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by Wuhan General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879293

Contacts
Contact: Xiang Guangda, MD +8602768878410 Guangda64@hotmail.com

Locations
China, Hubei
Wuhan General Hospital Recruiting
Wuhan, Hubei, China, 430070
Contact: Xiang Guangda, MD    +8602768878410    Guangda64@hotmail.com   
Sponsors and Collaborators
Wuhan General Hospital of Guangzhou Military Command
  More Information

No publications provided

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
Study First Received: June 11, 2013
Last Updated: September 4, 2013
Health Authority: China: Ethics Committee

Keywords provided by Wuhan General Hospital of Guangzhou Military Command:
Metformin
Left ventricular mass
Endothelial dysfunction
cardiac magnetic resonance
aortic pulse wave

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

ClinicalTrials.gov processed this record on July 23, 2014