TOPCAT, 2014 trial summary

A randomised clinical trial investigating the effect of spironolactone versus placebo in patients with heart failure and a preserved left ventricular ejection fraction of 45% or more

NCT00094302    N Engl J Med 2014;370:1383-92  




Studied treatment spironolactone (15 to 45 mg daily)
Control treatment placebo



Patients patients with heart failure and a preserved left ventricular ejection fraction of 45% or more
Group sizes 3445 / 0



Blindness double-blind Inclusion period
Follow-up duration 3.3 years Centers
Lost to FU geographical localisation
Primary endpoint CV death, hospitalization for HF Design Parallel groups



EndpointX1N1X0N0TE95% CI DC CV + hospitalization for HF - 3445 - 0 no data CV death - 3445 - 0 no data all cause death - 3445 - 0 no data HF hospitalization - 3445 - 0 no data0,22,01,0


Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM Spironolactone for heart failure with preserved ejection fraction. N Engl J Med 2014;370:1383-92     [PMID: 24716680]   link to pdf  



Registering number NCT00094302 (see trial on clinicaltrials.gov)
Code Name