Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease
Primary Purpose
Left Ventriclar Mass
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Metformin
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Left Ventriclar Mass focused on measuring Metformin, Left ventricular mass, Endothelial dysfunction, cardiac magnetic resonance, aortic pulse wave
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.
Sites / Locations
- Wuhan General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Metformin group
Placebo group
Arm Description
In this group, metformin 0.5 three times daily for one year.
In this group, placebo will be given twice daily for one year.
Outcomes
Primary Outcome Measures
Left ventricular mass.
We will measure left ventricular mass before and after metformin intervention with cardiac magnetic resonance.
Secondary Outcome Measures
Left ventricular volume and endothelial function.
We measure the left ventricular volume and endothelial function before and after metformin intervention by cardiac magnetic resonance and high resolution ultrasound.
Full Information
NCT ID
NCT01879293
First Posted
June 11, 2013
Last Updated
August 15, 2015
Sponsor
Wuhan General Hospital of Guangzhou Military Command
1. Study Identification
Unique Protocol Identification Number
NCT01879293
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan General Hospital of Guangzhou Military Command
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventriclar Mass
Keywords
Metformin, Left ventricular mass, Endothelial dysfunction, cardiac magnetic resonance, aortic pulse wave
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin group
Arm Type
Experimental
Arm Description
In this group, metformin 0.5 three times daily for one year.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
In this group, placebo will be given twice daily for one year.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Left ventricular mass.
Description
We will measure left ventricular mass before and after metformin intervention with cardiac magnetic resonance.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Left ventricular volume and endothelial function.
Description
We measure the left ventricular volume and endothelial function before and after metformin intervention by cardiac magnetic resonance and high resolution ultrasound.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Wuhan General Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
12. IPD Sharing Statement
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Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease
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