Effects of Eplerenone on Left Ventricular Remodelling Following Heart Attack
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|ClinicalTrials.gov Identifier: NCT00132093|
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : April 10, 2006
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Drug: Eplerenone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
- 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
- Comparison of lab blood markers of LV remodelling over 6 months, comparing treatment group to placebo group
- Comparison of neurohormonal levels over 6 months, comparing treatment group to placebo group
- Comparison of cardiac electrical stability (heart rate variability, QT dispersion) over 6 months, comparing treatment group to placebo group
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT00132093
|Glasgow, Scotland, United Kingdom, G11 6NT|
|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|