Not Signed In -
Death And Dying |
Advance Directives; End of Life; Living Wills |
Clinical Trial: A Comparison Of The Endpoints Of Death From A Cardiovascular Cause and Hospitalization For Worsening Heart Failure, In Patients Who Have NYHA Class II Heart Failure When They Are Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Med
This study is not yet open for patient recruitment.
Verified by Pfizer November 2005
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Purpose
In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, we do not know 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
| Condition | Intervention | Phase |
|---|---|---|
| Heart Failure | Drug: Eplerenone | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Further study details as provided by Pfizer:
Primary Outcomes: Cardiovascular mortality or heart failure hospitalization
Secondary Outcomes: All cause mortality or heart failure hospitalization; cardiovascular mortality; heart failure hospitalization
Expected Total Enrollment: 2584
Secondary Outcomes: All cause mortality or heart failure hospitalization; cardiovascular mortality; heart failure hospitalization
Expected Total Enrollment: 2584
Study start: January 2006
Eligibility
Ages Eligible for Study: 60 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Hx of chronic systolic heart failure of ischemic or non-ischemic etiology of at least 4 weeks duration
- Usually NYHA functional Class II and on optimal dose, or maximally tolerated dose of standard heart failure medicines (advisable to include ACE-I/ARBs
- beta-blockers and diuretics if indicated for fluid overload
Exclusion Criteria:
- Severe chronic systolic heart failure symptomatic at rest despite optimal medical therapy
- estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00232180
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A6141079
Last Updated: December 8, 2005
Record first received: September 30, 2005
ClinicalTrials.gov Identifier: NCT00232180
Health Authority: Germany: Ethics Commission
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: September 30, 2005
ClinicalTrials.gov Identifier: NCT00232180
Health Authority: Germany: Ethics Commission
ClinicalTrials.gov processed this record on 2006-01-10
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