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
Last updated date
ABOUT THIS STUDY
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
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Heart Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
55 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- History (Hx) of chronic systolic heart failure of ischemic or non-ischemic etiology of at least 4 weeks duration; Currently, New York Heart Association (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. Should have participated in the double-blind phase of the EMPHASIS-HF trial
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Severe chronic systolic heart failure symptomatic at rest despite optimal medical
therapy; estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2.
NEED INFO?
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Heart FailureA 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
- Phoenix, Arizona
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- Merced, California
- Stockton, California
- Colorado Springs, Colorado
- Bridgeport, Connecticut
- Hartford, Connecticut
- Washington, District of Columbia
- Daytona Beach, Florida
- Gainesville, Florida
- Jupiter, Florida
- Melbourne, Florida
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- Indianapolis, Indiana
- Indianapolis, Indiana
- Louisville, Kentucky
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- Louisville, Kentucky
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- Bangor, Maine
- Annapolis, Maryland
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- Boston, Massachusetts
- Minneapolis, Minnesota
- MN, Minnesota
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- Omaha, Nebraska
- Omaha, Nebraska
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- Albany, New York
- Rochester, New York
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- Oklahoma City, Oklahoma
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- Goettingen,
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- Republic Of Korea, Korea
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- Guadalajara, Jalisco
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | 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 | |||
| Official Title ICMJE | The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure | |||
| 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 | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Heart Failure | |||
| Intervention ICMJE | Drug: Eplerenone
Eplerenone administered on top of background standard heart failure therapy | |||
| Study Arms ICMJE | Active Comparator: Eplerenone arm
Eplerenone administered on top of background standard heart failure therapy Intervention: Drug: Eplerenone | |||
| Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 2743 | |||
| Original Enrollment ICMJE | 2584 | |||
| Actual Study Completion Date ICMJE | January 2012 | |||
| Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 55 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Argentina, Australia, Belgium, Canada, Czechia, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Ukraine, United Arab Emirates, United Kingdom, United States, Venezuela | |||
| Removed Location Countries | Czech Republic, Egypt, Jordan, Lebanon | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00232180 | |||
| Other Study ID Numbers ICMJE | A6141079 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||