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Effects of Eplerenone on Left Ventricular Remodelling Following Heart Attack

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00132093
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : April 10, 2006
Information provided by:
NHS Greater Glasgow and Clyde

Brief 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Eplerenone Phase 4

Detailed Description:

Despite advances in detection and treatment of coronary artery disease, and numerous campaigns to promote healthier lifestyles, ischaemic heart disease (IHD) remains very common worldwide but particularly in the West of Scotland. Following a heart attack, the main pumping chamber - the left ventricle (LV) - will be significantly damaged in around 40% of patients to the extent that it fails to pump as effectively as before. Despite current medical treatment, this failing LV slowly but continuously deteriorates with time (this is known as LV remodelling), which can lead to "heart failure".

Eplerenone, a hormone blocker (aldosterone antagonist), has been shown to reduce death rates and improve symptoms in patients with acute heart attacks - or myocardial infarctions (MI)- who additionally have impaired LV function and heart failure (or diabetes). The researchers assume that eplerenone may exert some of these beneficial effects by preventing or reducing this LV remodelling process.

Cardiac MRI provides very accurate assessment of LV function, such that small numbers of patients only are required to detect differences in LV function over time when comparing one group against another. The researchers are therefore comparing sequential cardiac MRI appearances and measurements in patients with acute MI and LV impairment at baseline (within 2 weeks of the acute MI), 3 months and 6 months. After the first MRI scan, patients are assigned to eplerenone or placebo in addition to usual secondary preventive therapy (double-blinded), which continues for 6 months, after which each patient's involvement in the trial is finished.

As eplerenone has been shown to benefit those with acute MI plus LV impairment and heart failure (or diabetes), such patients cannot ethically be put into a trial in which they may potentially be placed in a placebo group. For this reason, a slightly different cohort of patients are being used - acute MI with LV impairment but without clinical heart failure or diabetes.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effects of Eplerenone on Left Ventricular Remodelling Post-Acute Myocardial Infarction: a Double-Blind Placebo-Controlled Cardiac MR-Based Study
Study Start Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Eplerenone

Primary Outcome Measures :
  1. Change in left ventricular (LV) end-systolic volume over 6 months, based on cardiac magnetic resonance imaging (MRI) measurements, comparing treatment group to placebo group

Secondary Outcome Measures :
  1. Comparison of lab blood markers of LV remodelling over 6 months, comparing treatment group to placebo group
  2. Comparison of neurohormonal levels over 6 months, comparing treatment group to placebo group
  3. Comparison of cardiac electrical stability (heart rate variability, QT dispersion) over 6 months, comparing treatment group to placebo group
  4. Analysis of DNA at baseline between and within the eplerenone group and the control group - to see if mutations in the gene that encodes aldosterone synthase - CYP112B - predict remodelling and response to aldosterone blockade

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00132093

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United Kingdom
Western Infirmary
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
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Principal Investigator: Robin AP Weir, MBChB, BSc, MRCP NHS Greater Glasgow and Clyde
Study Director: Henry J Dargie, MBChB,FRCP NHS Greater Glasgow and Clyde
Study Director: John JV McMurray, FRCP,MD,FESC University of Glasgow
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00132093    
Other Study ID Numbers: WN04CA024
Eudract number 2004-004399-35
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: April 10, 2006
Last Verified: November 2004
Keywords provided by NHS Greater Glasgow and Clyde:
Left ventricular remodelling
Acute myocardial infarction
Left ventricular dysfunction
Cardiac Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Myocardial Infarction
Ventricular Remodeling
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents