Renal Hemodynamic Effects of RLX030A in Subjects With Chronic Heart Failure (CHF)

Phase 2 Completed 118 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2012-02
Primary completion: 2012-12
Completion: 2012-12

Outcome

Mixed primary results

paper Renal plasma flow increased by 29% with serelaxin and 14% with placebo (13% relative increase with serelaxin; P=0.0386) PMID 25286914 ↗

paper whereas GFR changes did not differ significantly during 8 to 24 hours. PMID 25286914 ↗

Publications

Voors AA, Dahlke M, Meyer S, Stepinska J, Gottlieb SS, Jones A, Zhang Y, Laurent D, Slart RH, Navis GJ. Renal hemodynamic effects of serelaxin in patients with chronic heart failure: a randomized, placebo-controlled study. Circ Heart Fail. 2014 Nov;7(6):994-1002. doi: 10.1161/CIRCHEARTFAILURE.114.001536. Epub 2014 Oct 6.

Drugs

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