Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232180
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2005-09-30
Brief Title:
A Comparison Of Outcomes In Patients In New York Heart Association NYHA Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure
Status:
COMPLETED
Status Verified Date:
2020-12
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:
EMPHASIS-HF
Brief Summary:
In an earlier study eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack However it is not known how patients with established mild-to-moderate heart failure NYHA Class II who have the additional risk of sudden death will respond if treated with eplerenone In this trial eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients
The Data Safety Monitoring Committee DSMC observed during its conduct of the protocol-specified second interim analysis on the 6th of May 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol As a result of the discussion between the DSMC and the Executive Steering Committee ESC the ESC recommended that EMPHASIS-HF should be terminated Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone The Open Label Extension eplerenone arm will last for 12 months Eplerenone is not currently approved for the indication studied in this patient population
On May 26 2010 further enrollment into EMPHASIS-HF was stopped The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone
The Data Safety Monitoring Committee DSMC observed during its conduct of the protocol-specified second interim analysis on the 6th of May 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol As a result of the discussion between the DSMC and the Executive Steering Committee ESC the ESC recommended that EMPHASIS-HF should be terminated Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone The Open Label Extension eplerenone arm will last for 12 months Eplerenone is not currently approved for the indication studied in this patient population
On May 26 2010 further enrollment into EMPHASIS-HF was stopped The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone
Detailed Description:
None
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