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document
Spironolactone for heart failure with preserved ejection fraction . BACKGROUND Mineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction . We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction . METHODS In this randomized , double-blind trial , we assigned 3445 patients with symptomatic heart failure and a left ventricular ejection fraction of 45 % or more to receive either spironolactone ( 15 to 45 mg daily ) or placebo . The primary outcome was a composite of death from cardiovascular causes , aborted cardiac arrest , or hospitalization for the management of heart failure . RESULTS With a mean follow-up of 3.3 years , the primary outcome occurred in 320 of 1722 patients in the spironolactone group ( 18.6 % ) and 351 of 1723 patients in the placebo group ( 20.4 % ) ( hazard ratio , 0.89 ; 95 % confidence interval [ CI ] , 0.77 to 1.04 ; P=0.14 ) . Of the components of the primary outcome , only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group ( 206 patients [ 12.0 % ] vs. 245 patients [ 14.2 % ] ; hazard ratio , 0.83 ; 95 % CI , 0.69 to 0.99 , P=0.04 ) . Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone . Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia ( 18.7 % , vs. 9.1 % in the placebo group ) but reduced hypokalemia . With frequent monitoring , there were no significant differences in the incidence of serious adverse events , a serum creatinine level of 3.0 mg per deciliter ( 265 μmol per liter ) or higher , or dialysis . CONCLUSIONS In patients with heart failure and a preserved ejection fraction , treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes , aborted cardiac arrest , or hospitalization for the management of heart failure . ( Funded by the National Heart , Lung , and Blood Institute ; TOPCAT ClinicalTrials.gov number , NCT00094302 . ) .
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Intervention_Pharmacological
Spironolactone
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Intervention_Pharmacological
spironolactone
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Intervention_Pharmacological
spironolactone
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Intervention_Control
placebo
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Intervention_Pharmacological
spironolactone
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Intervention_Control
placebo
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Intervention_Pharmacological
spironolactone
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Intervention_Control
placebo
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Intervention_Pharmacological
spironolactone .
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Intervention_Pharmacological
spironolactone
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Outcome_Other
effects
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Outcome_Mortality
death from cardiovascular causes
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Outcome_Physical
aborted cardiac arrest
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Outcome_Other
hospitalization for heart failure
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Outcome_Mortality
total deaths
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Outcome_Other
hospitalizations
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Outcome_Physical
serum creatinine levels
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Outcome_Physical
rate of hyperkalemia
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Outcome_Physical
serum creatinine level
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Participant_Condition
heart failure
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Participant_Condition
heart failure and a preserved left ventricular ejection fraction
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Participant_Sample-size
3445
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Participant_Condition
symptomatic heart failure and a left ventricular ejection fraction of 45 % or more