Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

Phase 2 Completed 71 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will assess the hemodynamic effect of RLX030 infusion in subjects with acute heart failure. In addition safety and effects on renal function and biomarkers will be assessed.

Timeline

Start: 2012-03
Primary completion: 2013-01
Completion: 2013-01

Outcome

Mixed primary results

paper Co-primary endpoints were peak change from baseline in PCWP and cardiac index (CI) during the first 8 h of infusion. PMID 24255129 ↗

paper those treated with serelaxin had a significantly higher decrease in peak PCWP during the first 8 h of infusion (difference vs. placebo: -2.44 mmHg, P = 0.004). PMID 24255129 ↗

paper Serelaxin showed no significant effect on the peak change in CI vs. placebo. PMID 24255129 ↗

Publications

Ponikowski P, Mitrovic V, Ruda M, Fernandez A, Voors AA, Vishnevsky A, Cotter G, Milo O, Laessing U, Zhang Y, Dahlke M, Zymlinski R, Metra M. A randomized, double-blind, placebo-controlled, multicentre study to assess haemodynamic effects of serelaxin in patients with acute heart failure. Eur Heart J. 2014 Feb;35(7):431-41. doi: 10.1093/eurheartj/eht459. Epub 2013 Nov 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Serelaxin	Protein / enzyme biologic	30 ug/kg	Intravenous