The effects of eplerenone on left ventricular remodelling post-acute myocardial infarction: a double-blind placebo-controlled cardiac MR-based study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004399-35-GB

Enrollment

100

Registered

2005-02-15

Start date

2005-01-18

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

Trade Name: Inspra 25 mg and 50 mg film-coated tablets. Product Name: Inspra Product Code: PL 00057/0615, 0616 Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 or above 2. Acute myocardial infarction as defined by standard criteria 3. LVSD based on echocardiographic WMSI and LVEF =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ; Secondary Objective: 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 ;Primary end point(s): The primary end-point will be LV end systolic volume index (LVESV)	—

Measure

Time frame

Main Objective: 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. ; Secondary Objective: 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 ;Primary end point(s): The primary end-point will be LV end systolic volume index (LVESV)

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026