A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients(RELAX-AHF-2)
Executive Committee: Peter Pang, MD
US Country Lead: Phillip Levy, MD, MPH
Sponsor: Novartis Pharmaceuticals
This Phase IIIb outcome study in AHF patients is designed as a multicenter, randomized, double blind, placebo-controlled, event-driven study in order to assess the efficacy, safety and tolerability of intravenous infusion of serelaxin or placebo. Serelaxin is a vasodilating neurohormone released in pregnancy that demonstrated promising results in a pivotal Phase IIIa trial involving acute heart failure patients, showing improved dyspnea and a decrease 180 day CV mortality. AHF patients in RELAX-AHF 2 are randomized to either serelaxin or placebo and followed for a period of 180 days. All enrolled patients are required to receive standard-of-care background HF management during both the index hospitalization and post discharge according to regional or local guidelines/institutional standards. Recruitment for RELAX-AHF 2 closed on July 26, 2016 with a total of 6605 patients enrolled. Data are currently in review.