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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
NCT00232180 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- DRUG Eplerenone
Study Locations (20)
Florida
- Pfizer Investigational Site — Daytona Beach
- Pfizer Investigational Site — Gainesville
- Pfizer Investigational Site — Jupiter
- Pfizer Investigational Site — Melbourne
California
- Pfizer Investigational Site — Loma Linda
- Pfizer Investigational Site — Merced
- Pfizer Investigational Site — Stockton
Kentucky
- Pfizer Investigational Site — Louisville
- Pfizer Investigational Site — Louisville
- Pfizer Investigational Site — Louisville
Connecticut
- Pfizer Investigational Site — Bridgeport
- Pfizer Investigational Site — Hartford
Indiana
- Pfizer Investigational Site — Indianapolis
- Pfizer Investigational Site — Indianapolis
Arizona
- Pfizer Investigational Site — Phoenix
Colorado
- Pfizer Investigational Site — Colorado Springs
District of Columbia
- Pfizer Investigational Site — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,743 participants |
| Start Date | 2006-03 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00232180
The ClinicalTrials.gov registry entry for NCT00232180 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,743 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 27 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which Eplerenone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00232180 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00232180 about?
NCT00232180 is a clinical study titled "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". 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 t...
What is the current status of trial NCT00232180?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,743 participants. The study started on 2006-03. Estimated completion is 2012-01.
What conditions does trial NCT00232180 study?
This clinical trial studies the following conditions: Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00232180?
The interventions under investigation include: Eplerenone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00232180?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 27 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00232180 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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