CMR to Assess Fibrosis in Cardiomyopathy Using Eplerenone

NCT00401856 | Completed Phase 4

• 2 other identifiers: 2004CD006BEudract 2004-002494-23
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine if therapy with the aldosterone antagonist, Eplerenone, is associated with improved remodeling of the left ventricle in patients with cardiomyopathy. We will determine if any benefit to cardiac remodeling is associated with improved clinical outcomes, including improved exercise capacity and reduced incidence of major adverse cardiac events such as death, hospitalization for heart-failure, serious heart rhythm disturbances and transplantation. The null hypothesis is that therapy with Eplerenone over 12 months is associated with an improvement in cardiopulmonary exercise capacity and furthermore that treatment is associated with improved clinical outcomes. In order to test this hypothesis we will study stable patients on optimal drug therapy with documented cardiomyopathy using a trial design where therapy will be randomized, double-blinded and placebo-controlled. This will reduce the likelihood of any 'researcher bias'. Patients will be recruited from the Heart-failure Service at the Royal Brompton Hospital.

Conditions

Cardiomyopathy

Keywords

Cardiomyopathy; Fibrosis; Magnetic-Resonance; Eplerenone

Outcome Measures

Primary Outcomes (1)

• Improvement in MVO2

  6 months

Secondary Outcomes (1)

• Reduction in major adverse cardiovascular events

  6 months

Study Arms (2)

1

EXPERIMENTAL

This arm will receive eplerenone

Drug: Eplerenone

2

PLACEBO COMPARATOR

This group will receive the placebo

Drug: Placebo

Interventions

Eplerenone DRUG

50mg oral route

1

Placebo DRUG

Placebo is identical to eplerenone but the active ingredient is absent

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients already established on treatment with an aldosterone antagonist
• Patients with contraindications to eplerenone (hyperkalaemia, renal failure)
• Critically ill patients requiring respiratory and/or circulatory support
• Pacemaker or ICD
• Implanted ferromagnetic cerebrovascular clips
• Pregnant women (precautionary only)
• Intolerance of confined spaces
• Inability to lie supine for 60 minutes
• Unwilling or unable to give written informed consent
• Atrial fibrillation or ventricular bigemini.
• Any contraindication to CMR.
• Recent MI
• HCM patients who have received surgical/alcohol ablation treatment

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton & Harefield NHS Trust

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Cardiomyopathies; Fibrosis

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sanjay Prasad, MD, MRCP

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: December 1, 2007
• Primary Completion: April 2, 2013
• Study Completion: April 2, 2013
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

GB (1)