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Effects of Eplerenone on Left Ventricular Remodelling Following Heart Attack

NCT ID: NCT00132093

Last Updated: 2006-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Eplerenone

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Principal Investigators

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Robin AP Weir, MBChB, BSc, MRCP

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Henry J Dargie, MBChB,FRCP

Role: STUDY_DIRECTOR

NHS Greater Glasgow and Clyde

John JV McMurray, FRCP,MD,FESC

Role: STUDY_DIRECTOR

University of Glasgow

Locations

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Western Infirmary

Glasgow, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

References

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Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B, Bittman R, Hurley S, Kleiman J, Gatlin M; Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study Investigators. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003 Apr 3;348(14):1309-21. doi: 10.1056/NEJMoa030207. Epub 2003 Mar 31.

Reference Type BACKGROUND
PMID: 12668699 (View on PubMed)

Weir RA, Petrie CJ, Murphy CA, Clements S, Steedman T, Miller AM, McInnes IB, Squire IB, Ng LL, Dargie HJ, McMurray JJ. Galectin-3 and cardiac function in survivors of acute myocardial infarction. Circ Heart Fail. 2013 May;6(3):492-8. doi: 10.1161/CIRCHEARTFAILURE.112.000146. Epub 2013 Mar 15.

Reference Type DERIVED
PMID: 23505301 (View on PubMed)

Weir RA, Tsorlalis IK, Steedman T, Dargie HJ, Fraser R, McMurray JJ, Connell JM. Aldosterone and cortisol predict medium-term left ventricular remodelling following myocardial infarction. Eur J Heart Fail. 2011 Dec;13(12):1305-13. doi: 10.1093/eurjhf/hfr129. Epub 2011 Sep 22.

Reference Type DERIVED
PMID: 21940729 (View on PubMed)

Weir RA, Clements S, Steedman T, Dargie HJ, McMurray JJ, Squire IB, Ng LL. Plasma TIMP-4 predicts left ventricular remodeling after acute myocardial infarction. J Card Fail. 2011 Jun;17(6):465-71. doi: 10.1016/j.cardfail.2011.02.002. Epub 2011 Mar 25.

Reference Type DERIVED
PMID: 21624734 (View on PubMed)

Weir RA, Murphy CA, Petrie CJ, Martin TN, Balmain S, Clements S, Steedman T, Wagner GS, Dargie HJ, McMurray JJ. Microvascular obstruction remains a portent of adverse remodeling in optimally treated patients with left ventricular systolic dysfunction after acute myocardial infarction. Circ Cardiovasc Imaging. 2010 Jul;3(4):360-7. doi: 10.1161/CIRCIMAGING.109.897439. Epub 2010 Mar 26.

Reference Type DERIVED
PMID: 20348438 (View on PubMed)

Weir RA, Miller AM, Murphy GE, Clements S, Steedman T, Connell JM, McInnes IB, Dargie HJ, McMurray JJ. Serum soluble ST2: a potential novel mediator in left ventricular and infarct remodeling after acute myocardial infarction. J Am Coll Cardiol. 2010 Jan 19;55(3):243-50. doi: 10.1016/j.jacc.2009.08.047.

Reference Type DERIVED
PMID: 20117403 (View on PubMed)

Weir RA, Martin TN, Murphy CA, Petrie CJ, Clements S, Steedman T, Dargie HJ, Wagner GS. Comparison of serial measurements of infarct size and left ventricular ejection fraction by contrast-enhanced cardiac magnetic resonance imaging and electrocardiographic QRS scoring in reperfused anterior ST-elevation myocardial infarction. J Electrocardiol. 2010 May-Jun;43(3):230-6. doi: 10.1016/j.jelectrocard.2010.01.003. Epub 2010 Feb 1.

Reference Type DERIVED
PMID: 20116803 (View on PubMed)

Weir RA, Mark PB, Petrie CJ, Clements S, Steedman T, Ford I, Ng LL, Squire IB, Wagner GS, McMurray JJ, Dargie HJ. Left ventricular remodeling after acute myocardial infarction: does eplerenone have an effect? Am Heart J. 2009 Jun;157(6):1088-96. doi: 10.1016/j.ahj.2009.04.001.

Reference Type DERIVED
PMID: 19464421 (View on PubMed)

Iraqi W, Rossignol P, Angioi M, Fay R, Nuee J, Ketelslegers JM, Vincent J, Pitt B, Zannad F. Extracellular cardiac matrix biomarkers in patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure: insights from the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) study. Circulation. 2009 May 12;119(18):2471-9. doi: 10.1161/CIRCULATIONAHA.108.809194. Epub 2009 Apr 27.

Reference Type DERIVED
PMID: 19398668 (View on PubMed)

Weir RA, Chong KS, Dalzell JR, Petrie CJ, Murphy CA, Steedman T, Mark PB, McDonagh TA, Dargie HJ, McMurray JJ. Plasma apelin concentration is depressed following acute myocardial infarction in man. Eur J Heart Fail. 2009 Jun;11(6):551-8. doi: 10.1093/eurjhf/hfp043. Epub 2009 Apr 6.

Reference Type DERIVED
PMID: 19351633 (View on PubMed)

Weir RA, Martin TN, Petrie CJ, Murphy A, Clements S, Steedman T, Wagner GS, McMurray JJ, Dargie HJ. Cardiac and extracardiac abnormalities detected by cardiac magnetic resonance in a post-myocardial infarction cohort. Cardiology. 2009;113(1):1-8. doi: 10.1159/000161233. Epub 2008 Oct 10.

Reference Type DERIVED
PMID: 18849604 (View on PubMed)

Other Identifiers

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Eudract number 2004-004399-35

Identifier Type: -

Identifier Source: secondary_id

WN04CA024

Identifier Type: -

Identifier Source: org_study_id