Effects of Eplerenone on Left Ventricular Remodelling Following Heart Attack

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 occur within the heart muscle, that lead ultimately to weakening of the heart muscle and premature death.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NHS Greater Glasgow and Clyde
• Treatments: Eplerenone; Spironolactone

Criteria

Inclusion Criteria:

1. Age 18 or above

2. 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)

3. Left ventricular systolic dysfunction (LVSD) based on echocardiographic wall motion score index (WMSI) and left ventricular ejection fraction (LVEF) < 40%

4. Ability to give written informed consent

Exclusion Criteria:

1. Clinical or radiological heart failure

2. Established diabetes mellitus

3. Current use of potassium (K)-sparing diuretics, clarithromycin, nefazodone, itraconazole, ketoconazole, ritonavir, nelfinavir, tacrolimus, cyclosporin.

4. Serum creatinine > 220 µmol/l

5. Serum potassium > 5.0 mmol/l

6. Pregnancy

7. Addison's disease

8. MRI-incompatible (ferrous) sulphate prosthesis

9. Claustrophobia (unable to tolerate MR environment)

10. Concurrent use of phenytoin, carbamazepine, rifampicin or St. John's Wort (reduce efficacy of eplerenone).