Ularitide has been studied for the treatment of acute heart failure (AHF) in two double-blind, placebo-controlled Phase I1 and Phase II2 studies (Safety and efficacy of an Intravenous placebo controlled Randomised Infusion of Ularitide in a prospective double – blind Study in patients with symptomatic, decompensated chronic heart failure – SIRIUS I and SIRIUS II).
SIRIUS I was a randomised, double-blind, ascending-dose study. Twenty four patients with AHF received 24 hour IV infusion of placebo or ularitide at 7.5, 15, or 30 ng/kg/min in addition to standard therapy.
The SIRIUS II study was a placebo controlled, double-blind, parallel-group study, which randomised 221 patients with AHF to one of three different ularitide doses of 7.5 ng/kg/min (n=60), 15 ng/kg/min (n=53) and 30 ng/kg/min (n=55) or to placebo (N=53), which were administered in addition to standard therapy.
1. Mitrovic V, Lüss H, Nitsche K, et al. Effects of the renal natriuretic peptide urodilatin (ularitide) in patients with decompensated chronic heart failure: A double-blind, placebo-controlled, ascending-dose trial. Am Heart J. 2005;150:1239.e1-1239.e8.
2. Mitrovic V, Seferovic P, Simeunovic D, et al. Haemodynamic and clinical effects of ularitide in decompensated heart failure. Euro Heart J 2006; 27, 2823-2832.