The effect of eplerenone versus placebo on cardiovascular mortality and heart failure hospitalization in subjects with NYHA Class II Chronic Systolic Heart Failure

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2584

Inclusion Criteria

1. Written informed consent obtained prior to the initiation of any study procedures
2. Male or female subjects, =60 years of age at the time informed consent is obtained
3. Chronic systolic heart failure (HF) of either ischemic or non-ischemic etiology:
a) Duration: at least 4 weeks
b) Left ventricular ejection fraction (LVEF): =30% by echocardiography, contrast
ventriculography or nuclear imaging
c) Functional Capacity: Usually NYHA II (in the investigator’s opinion)
d) Treatments (for ACE inhibitors, ARBs and b-blockers, optimal target or maximal
tolerated dose [see Appendix 1 of the protocol] unless contraindicated):
i) Angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor
blockers (ARBs)
ii) b-blocker
iii) Diuretic, if clinically indicated to reduce fluid retention
4. Serum potassium (K+) level =5.0mmol/L
5. Estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 (see Appendix 2 of the protocol)
6. Randomization must occur no later than 90 days from the date of admission for index cardiovascular (CV) hospitalization. (If clinically stable, the subject may be randomized during this index cardiovascular (CV) hospitalization.)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with severe chronic systolic heart failure, defined as patients who demonstrate symptoms usually at rest despite optimal medical therapy
2. Patients with a myocardial infarction complicated by left ventricular systolic dysfunction and clinical heart failure within 30 days prior to randomization
3. Patients, who in the opinion of the investigator, require treatment with eplerenone or spironolactone
4. Patients, who in the opinion of the investigator, require treatment with potassium-sparing diuretics or potassium supplements
5. History of hypersensitivity to eplerenone or spironolactone
6. Evidence of cardiogenic shock
7. Intra-aortic balloon pump or other mechanical assist device
8. Patients awaiting cardiac transplantation
9. Serum potassium > 5.0 mmol/L within 24 hours prior to randomization
10. Estimated glomerular filtration rate (eGFR) =30 ml/min/1.73m2 within 24 hours prior to randomization (see Appendix 2 of the protocol)
11. Concomitant use of potent cytochrome p450 3A4 (CYP3A4) inhibitors, such as but not limited to:
a. Ketoconazole
b. Itraconazole
c. Nefazodone
d. Troleandomycin
e. Clarithromycin
f. Ritonavir
g. Nelfinavir
12. Patients with significant hepatic disease, defined as follows:
EITHER
h. Aspartate aminotransferase (AST) >3 times the upper limit of normal
AND/OR
i. Alanine aminotransferase (ALT) >3 times the upper limits of normal
AND/OR
j. Known positive serology for viral hepatitis
13. Patients status-post gastric bypass surgery, partial gastrectomy or other surgery of the gastrointestinal tract that may interfere with the absorption of eplerenone

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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