E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-myocardial infarction left ventricular dysfunction, in the absence of heart failure - clinical (i.e. Killip III or IV) or radiological - nor established diabetes mellitus. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to examine the early LV remodelling process in patients presenting to hospital with acute MI with LV dysfunction (as assessed by echocardiographic LVEF < 40%), over six months, comparing treatment with eplerenone v. placebo, assessed by CMR.
The hypothesis to be tested in this study is that eplerenone will attenuate the early LV remodelling process within the first six months compared to placebo.
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E.2.2 | Secondary objectives of the trial |
LV remodelling:
1.Compare lab markers of collagen turnover 2.Compare lab markers of coagulation-fibrinolytic 3.Compare cytokine analysis 4.Analyse aspects of endothelial function using CMR measure of aortic PWV/distensibility
Aldosterone antagonism:
1.Compare serum calcium and magnesium 2.Compare lab markers of neurohormonal function 3.Analyse 24hr urinary sodium excretion and aldosterone metabolites 4.Analyse DNA at baseline
Overall cardiovascular risk profile:
1.Measure homocysteine levels at baseline and see if these predict remodelling 2.Assess cardiac electrical stability 3.Compare symptom status |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Age 18 or above 2. Acute myocardial infarction as defined by standard criteria 3. LVSD based on echocardiographic WMSI and LVEF < 40% 4. Ability to give written informed consent.
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E.4 | Principal exclusion criteria |
1. Clinical or radiological heart failure 2. Established diabetes mellitus 3. Current use of K-sparing diuretics 4. Serum creatinine > 220mmol/l 5. Serum potassium > 5.0mmol/l 6. Pregnancy 7. Addison’s disease 8. MRI-incompatible (ferrous) sulphate prosthesis 9. Claustrophobia (unable to tolerate MR environment)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end-point will be LV end systolic volume index (LVESV) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |