The phase III RELAX-AHF-2 study did not meet the primary endpoints reduced cardiovascular death or worsening heart failure in patients with acute heart failure. This was stated in a press release of Novartis today.
The RELAX-AHF-2 is an event-driven, multicentre, randomized, double-blind and placebo-controlled phase III study, in which the efficacy, safety and tolerability of RLX030 (serelaxin) were investigated when it was added to standard of care in patients with acute heart failure. The study had two primary endpoints; reduction of cardiovascular death through day 180 and occurrence of worsening heart failure through day 5. The RELAX-AHF-2 study included 6,600 patients hospitalized for acute heart failure and was initiated in October 2013.
RLX030, a relaxin receptor agonist, is a recombinant form of the naturally-occurring human relaxin-2 hormone. Human relaxin-2 is present in both men and women and elevated levels in pregnant women are thought to help the body cope with the additional cardiovascular demands during pregnancy.
Source Press release Novartis 22-03-2017
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