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EMPHASIS-HF TRIAL |
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|---|---|
| Problem | CCF (NYHA II & EF < 35%*) |
| Format | Double-blinded multi-center RCT |
| Treatment | Eplerenone |
| Control | Placebo |
| Population | 2737 patients |
| Inclusion criteria | Age > 55 years NYHA functional class II symptoms Ejection fraction of no more than 30% (or, if >30 to 35%, a QRS duration of >130 msec) Treatment with an angiotensin-converting–enzyme (ACE) inhibitor, an angiotensin-receptor blocker (ARB), or both and a beta-blocker (unless contraindicated) at the recommended dose or maximal tolerated dose. |
| Exclusion criteria | Acute myocardial infarction NYHA class III or IV heart failure Serum potassium > 5.0 mmol per liter eGFR < 30 ml per minute per 1.73 m2 Need for a potassium-sparing diuretic Any other clinically significant, coexisting condition. |
| Follow-up | Median 21 months |
| Primary endpoint | Composite of death from cardiovascular causes or a first hospitalization for heart failure |
| Secondary endpoint(s) | Hospitalization for heart failure or death from any cause Death from any cause Death from cardiovascular causes Hospitalization for any reason Hospitalization for heart failure (among others) |
| Details | * = Ejection fraction of no more than 30% (or, if >30 to 35%, a QRS duration of >130 msec) Patients were randomized to two placebo or eplerenone 25 mg once daily. This dosage increased to 50 mg once daily after 4 weeks or 25 mg on alternate days increased to 25 mg daily. Serum potassium levels were used to guide dose increases and decreases. |
| Brief summary: | Eplereonone reduced mortality and symptoms in NYHA 2+ |
| PAPER: Eplerenone in patients with systolic heart failure and mild symptoms. | |
|---|---|
| Date | 6 Jan 2011 |
| Journal | N Engl J Med. 2011 Jan 6;364(1):11-21. |
| Information | Eplerenone vs. placebo -37% reduction in death from CV causes or hospitalisation for HF --Benefits across all prespecified subgroups -Significant reduction in death from any cause -Trend towards fewer adverse events in eplerenone group --Significantly increased risk of hyperkalaemia |