Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure, CHF, Heart Failure, HF, Immunogenicity, Anti-bodies, Hypersensitivity, Serelaxin, RELAX-REPEAT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 321
Healthy volunteers: no

Brief summary:
The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic heart failure.

Detailed description:

Arms:
arm 1: Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8 arm 2: Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8

Interventions: intervention 1: RLX030 (serelaxin) intervention 2: Placebo
Intervention descriptions: intervention 1: RLX030 (serelaxin) was administered according to a weight-range adjusted dosing regimen at a nominal dose of 30 μg/kg/day as a continuous IV infusion for 48 hours. intervention 2: Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours.

Protocol document: