Status:
COMPLETED
Effects of Eplerenone on Left Ventricular Remodelling Following Heart Attack
Lead Sponsor:
NHS Greater Glasgow and Clyde
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to ascertain whether treatment with the drug eplerenone, taken early after a heart attack, prevents or reduces some of the adverse changes that may otherwise naturally occ...
Detailed Description
Despite advances in detection and treatment of coronary artery disease, and numerous campaigns to promote healthier lifestyles, ischaemic heart disease (IHD) remains very common worldwide but particul...
Eligibility Criteria
Inclusion
- Age 18 or above
- Acute myocardial infarction within last 1-14 days (defined by typical electrocardiogram \[ECG\] changes and/or elevated cardiac enzymes to at least twice the upper limit of normal)
- Left ventricular systolic dysfunction (LVSD) based on echocardiographic wall motion score index (WMSI) and left ventricular ejection fraction (LVEF) \< 40%
- Ability to give written informed consent
Exclusion
- Clinical or radiological heart failure
- Established diabetes mellitus
- Current use of potassium (K)-sparing diuretics, clarithromycin, nefazodone, itraconazole, ketoconazole, ritonavir, nelfinavir, tacrolimus, cyclosporin.
- Serum creatinine \> 220 µmol/l
- Serum potassium \> 5.0 mmol/l
- Pregnancy
- Addison's disease
- MRI-incompatible (ferrous) sulphate prosthesis
- Claustrophobia (unable to tolerate MR environment)
- Concurrent use of phenytoin, carbamazepine, rifampicin or St. John's Wort (reduce efficacy of eplerenone).
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00132093
Start Date
April 1 2005
Last Update
April 10 2006
Active Locations (1)
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1
Western Infirmary
Glasgow, Scotland, United Kingdom, G11 6NT