In fact, I won’t go into all the detail, but there is good evidence that both of those things I said are correct. As it turned out, the patients who were enrolled in Russia and Georgia perhaps didn’t have heart failure and maybe didn’t take their spironolactone, so they had a very low event rate, and there was no difference between spironolactone and placebo. The TOPCAT trial was an interesting trial because it was conducted in the, Canada, Brazil, and Argentina, as well as in Russia and Georgia. In other words, there was not a significant reduction in the primary composite end point, although there was a nominally significant reduction in heart failure hospitalization of around 15%. That trial compared spironolactone, a mineralocorticoid receptor antagonist or aldosterone antagonist, to placebo, and the overall result of the trial was not significant. John McMurray, MBChB: One of the large trials conducted in patients with HFpEF was the TOPCAT trial, which enrolled just under 3500 patients with heart failure and an ejection fraction of 45% or above.
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