Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Left Ventriclar Mass |
| Intervention | Drug: Metformin Drug: placebo |
| Phase | Phase 4 |
| Sponsor | Wuhan General Hospital of Guangzhou Military Command |
| Responsible Party | 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 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 11, 2013 |
|---|---|
| Last Updated Date | September 4, 2013 |
| Start Date | July 2013 |
| Estimated Primary Completion Date | December 2014 |
| Current 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. |
| Current 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. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease |
|---|---|
| Official Title | Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease:A Randomized, Double-Blind, Placebo-Controlled Study |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention |
| Condition | Left Ventriclar Mass |
| Intervention | Drug: Metformin Drug: placebo |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 120 |
| Estimated Completion Date | December 2014 |
| Estimated Primary Completion Date | December 2014 |
| Eligibility 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. |
| Gender | Both |
| Ages | 40 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Xiang Guangda, MD +8602768878410 Guangda64@hotmail.com |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01879293 |
|---|---|
| Other Study ID Numbers | 2013Wze028 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Wuhan General Hospital of Guangzhou Military Command |
| Study Sponsor | Wuhan General Hospital of Guangzhou Military Command |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | June 2013 |
Locations[ + expand ][ + ]
| Wuhan General Hospital | Wuhan, Hubei, China, 430070 Contact: Xiang Guangda, MD | +8602768878410 | Guangda64@hotmail.comRecruiting |
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