Status:
COMPLETED
MetfoRmin and Its Effects on Left Ventricular Hypertrophy in Normotensive Patients With Coronary Artery Disease
Lead Sponsor:
University of Dundee
Conditions:
Left Ventricular Hypertrophy
Insulin Resistance
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Thickening of the heart muscle (left ventricle) known medically as Left Ventricular Hypertrophy (LVH) is very common in patients with heart disease. This increases risk of cerebrovascular/cardiovascul...
Detailed Description
This is a single centre trial designed to investigate the benefit, if any, of 12 month metformin XL 2000mg/day treatment on left ventricular hypertrophy (LVH) in 64 nondiabetic participants with Ischa...
Eligibility Criteria
Inclusion
- Aged 18 years or over
- Participant willing and able to give informed consent.
- Documented Ischaemic Heart Disease: either angio-graphically documented coronary artery disease or a previous history of myocardial infarction/angina.
- Screening echocardiography based diagnosis of LVH (LV mass indexed to height to the allometric power of 1.7; males \> 81g/h1.7, females \>60g/h1.7)
- Fasting insulin resistance index ≥ 2.7 AND/OR HbA1c \>5.6 and less than 6.5 at screening
- Blood pressure \< 140/85 mm Hg or 24hr BP \<135/85 daytime average in screening
- Able (in the Investigators opinion) and willing to comply with all study requirements.
Exclusion
- Cognitive impairment
- Type 1 or 2 Diabetes mellitus
- Chronic Heart Failure as evidenced by echocardiogram or documented diagnosis of CHF
- Left Ventricular Ejection Fraction \<45% on screening echocardiography
- Contraindications to cardiac MRI (pacemakers, claustrophobia, metal implants, history of penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
- Malignancy (receiving active treatment) or other life threatening disease, renal disease (CKD class 3B or worse)
- Pregnancy/lactating females
- Any other reason considered inappropriate by a study physician
- Participants who have participated in any other clinical trial within the previous 30 days.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT02226510
Start Date
March 1 2015
End Date
December 1 2017
Last Update
April 10 2019
Active Locations (1)
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1
Ninewells Hospital & Medical School
Dundee, Angus, United Kingdom, DD1 9SY