placebo based on gender: women, 25.1% vs. Women were older with fewer comorbidities. There was no effect modification by AF for the primary endpoint for spironolactone vs. Post-randomization AF occurred in 6.3% of patients and was associated with an increased early risk of the primary outcome (HR 2.32, 95% CI 1.59-3.40, p < 0.0001). Patients with any history/prevalent AF had numerically higher incidence of the primary endpoint (12.1% vs. These patients had higher left atrial volumes than patients without AF. Influence of AF: AF was common, either based on ECG at enrollment (25%) or based on history (18%). 9.1%, p 2 upper limit of normal were both significantly higher in the spironolactone arm. CHF hospitalizations were lower (12.0% vs. 5 events, p = 0.48) were similar between the two arms. p = 0.35) and aborted cardiac arrest (3 vs. Individual components including CV mortality (9.3% vs. The primary endpoint of CV death, chronic HF (CHF) hospitalization, or resuscitated cardiac arrest over 6 years was similar between the spironolactone and placebo arms (18.6% vs. Close to 29% of patients were enrolled into stratum II (elevated B-type natriuretic peptide /N-terminal proBNP). Coexisting coronary artery disease was noted in 59% and atrial fibrillation (AF) in 35%. Hypertension was present in 92% of patients, with median blood pressure (BP) of 130/80 mm Hg. The baseline EF was 56%, 52% were female, and nearly two-thirds of the patients had New York Heart Association (NYHA) class II symptoms.
Baseline characteristics were fairly similar between the two arms. Concomitant Medications:Īngiotensin-converting enzyme inhibitor (ACEI)/angiotensin-receptor blocker (ARB) (84%), diuretic (82%), and statin (53%)Ī total of 3,445 patients were randomized at 233 sites in six countries: 1,722 to spironolactone and to 1,723 to placebo. Spironolactone was initiated at a dose of 15 mg/day and uptitrated to a maximum of 45 mg daily during the first 4 months of randomization. Patients were randomized in 1:1 fashion to either spironolactone versus placebo. Individual components of the composite outcome.Composite of CV mortality, aborted cardiac arrest, or hospitalization for the management of HF.Restrictive, infiltrative, or hypertrophic cardiomyopathy.Controlled systolic BP, defined as a target systolic BP 2.5 mg/dl.Left ventricular EF (LVEF) ≥45%, assessed within 6 months.