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
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Eplerenone
Intervention description: Eplerenone administered on top of background standard heart failure therapy
Intervention MeSH terms: Eplerenone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2743.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Open-label; single arm mortality/morbidity trial eplerenone chronic systolic heart failure

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
    

Eligibility criteria:

        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.