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A randomised, double-blinded, placebo-controlled trial using cardiovascular magnetic resonance (CMR) scanning to assess remodelling and regression of fibrosis in cardiomyopathy with eplerenone

A randomised, double-blinded, placebo-controlled trial using cardiovascular magnetic resonance (CMR) scanning to assess remodelling and regression of fibrosis in cardiomyopathy with eplerenone

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN23314770
Enrollment
140
Registered
2007-09-28
Start date
2006-10-27
Completion date
Unknown
Last updated
2017-10-30

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

Conditions

Cardiovascular: Cardiomyopathy Circulatory System Cardiomyopathy

Interventions

Eplerenone vs placebo

Sponsors

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Stable patients with an established diagnosis of cardiomyopathy as assessed by history, examination and typical ECG/Echo findings who are on maximally tolerated doses of appropriate drugs with no changes being made to the prescription in the 2 months preceding the start of the trial.

Exclusion criteria

Exclusion criteria: 1. Patients already established on treatment with an aldosterone antagonist 2. Patients with contraindications to eplerenone (hyperkalaemia, renal failure) 3. Critically ill patients requiring respiratory and/or circulatory support 4. Pacemaker or ICD 5. Implanted ferromagnetic cerebrovascular clips 6. Pregnant women (precautionary only) 7. Intolerance of confined spaces 8. Inability to lie supine for 60 minutes 9. Unwilling or unable to give written informed consent 10.Atrial fibrillation or ventricular bigeminy 11. Any contraindication to CMR. 12. Recent MI 13. HCM patients who have received surgical/alcohol ablation treatment

Design outcomes

Primary

MeasureTime frame
Reduction in amount of fibrosis as determined by CMR Late enhancement

Secondary

MeasureTime frame
1. Improvement in myocardial oxygen consumption (MVO2) 2. Reduction in major adverse cardiovascular events

Countries

United Kingdom

Outcome results

None listed

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