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

NCT ID: NCT00232180

Last Updated: 2020-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2743 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2012-01-31

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Eplerenone arm

Eplerenone administered on top of background standard heart failure therapy

Group Type ACTIVE_COMPARATOR

Eplerenone

Intervention Type DRUG

Eplerenone administered on top of background standard heart failure therapy

Interventions

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Eplerenone

Eplerenone administered on top of background standard heart failure therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* Severe chronic systolic heart failure symptomatic at rest despite optimal medical therapy; estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m2.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Bratislava, , Slovakia

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Levice, , Slovakia

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Jupiter, Florida, United States

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Melbourne, Florida, United States

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Rockford, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Bangor, Maine, United States

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Annapolis, Maryland, United States

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Columbia, Maryland, United States

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Boston, Massachusetts, United States

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Minneapolis, Minnesota, United States

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MN, Minnesota, United States

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Tupelo, Mississippi, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Chai Wan, , Hong Kong

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Shatin NT, , Hong Kong

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Budapest, , Hungary

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Debrecen, , Hungary

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Piotrkow Trybunalski, , Poland

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Coimbra, , Portugal

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Oliveira de Azeméis, , Portugal

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Porto, , Portugal

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Vila Real, , Portugal

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Moscow, , Russia

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Moscow, , Russia

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Voronezh, , Russia

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Yaroslavl, , Russia

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Singapore, , Singapore

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Singapore, , Singapore

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Liptovský Mikuláš, , Slovakia

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Trenčín, , Slovakia

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Soweto, Johannesburg, South Africa

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Taegu, , South Korea

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Falun, , Sweden

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Halmstad, , Sweden

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Hässleholm, , Sweden

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Skellefteå, , Sweden

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Varberg, , Sweden

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Glasgow, , United Kingdom

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Harrow, , United Kingdom

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Larbert, , United Kingdom

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Macclesfield, , United Kingdom

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Manchester, , United Kingdom

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Sheffield, , United Kingdom

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Southend-on-Sea, , United Kingdom

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Torquay, , United Kingdom

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Caracas, Distrito Federal, Venezuela

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Caracas, Miranda, Venezuela

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Caracas, Miranda, Venezuela

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Countries

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United States Argentina Australia Belgium Canada Czechia France Germany Greece Hong Kong Hungary India Ireland Italy Mexico Netherlands Poland Portugal Russia Singapore Slovakia South Africa South Korea Spain Sweden Ukraine United Arab Emirates United Kingdom Venezuela

References

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Butt JH, Solomon SD, Vaduganathan M, van Veldhuisen DJ, Kober L, Pitt B, Zannad F, Jhund PS, McMurray JJV. Mineralocorticoid receptor antagonists in heart failure with reduced ejection fraction according to body weight. Eur J Heart Fail. 2025 Apr 21. doi: 10.1002/ejhf.3665. Online ahead of print.

Reference Type DERIVED
PMID: 40256839 (View on PubMed)

Matsumoto S, Kondo T, Jhund PS, Campbell RT, Swedberg K, van Veldhuisen DJ, Pocock SJ, Pitt B, Zannad F, McMurray JJV. Underutilization of Mineralocorticoid Antagonists in Patients With Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2023 Sep 12;82(11):1080-1091. doi: 10.1016/j.jacc.2023.06.021.

Reference Type DERIVED
PMID: 37642608 (View on PubMed)

Vaduganathan M, Ferreira JP, Rossignol P, Neuen BL, Claggett BL, Pfeffer MA, McMurray JJV, Pitt B, Zannad F, Solomon SD. Effects of steroidal mineralocorticoid receptor antagonists on acute and chronic estimated glomerular filtration rate slopes in patients with chronic heart failure. Eur J Heart Fail. 2022 Sep;24(9):1586-1590. doi: 10.1002/ejhf.2635. Epub 2022 Aug 31.

Reference Type DERIVED
PMID: 35867859 (View on PubMed)

Martens P, Ferreira JP, Vincent J, Abreu P, Busselen M, Mullens W, Tang WHW, Bohm M, Pitt B, Zannad F, Rossignol P. Prognostic relevance of magnesium alterations in patients with a myocardial infarction and left ventricular dysfunction: insights from the EPHESUS trial. Eur Heart J Acute Cardiovasc Care. 2022 Feb 8;11(2):148-159. doi: 10.1093/ehjacc/zuab111.

Reference Type DERIVED
PMID: 35021200 (View on PubMed)

Ferreira JP, Lamiral Z, McMurray JJV, Swedberg K, van Veldhuisen DJ, Vincent J, Rossignol P, Pocock SJ, Pitt B, Zannad F. Impact of Insulin Treatment on the Effect of Eplerenone: Insights From the EMPHASIS-HF Trial. Circ Heart Fail. 2021 Jun;14(6):e008075. doi: 10.1161/CIRCHEARTFAILURE.120.008075. Epub 2021 Jun 15.

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Zannad F, McMurray JJ, Drexler H, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Rationale and design of the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF). Eur J Heart Fail. 2010 Jun;12(6):617-22. doi: 10.1093/eurjhf/hfq049. Epub 2010 Apr 13.

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A6141079

Identifier Type: -

Identifier Source: org_study_id

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