Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132093
Status:
COMPLETED
Last Update Posted:
2006-04-10
First Post:
2005-08-18
Brief Title:
Effects of Eplerenone on Left Ventricular Remodelling Following Heart Attack
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
NHS Greater Glasgow and Clyde
Study Overview
Official Title:
The Effects of Eplerenone on Left Ventricular Remodelling Post-Acute Myocardial Infarction a Double-Blind Placebo-Controlled Cardiac MR-Based Study
Status:
COMPLETED
Status Verified Date:
2004-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eudract number 2004-004399-35 | None | None | None |