Conditions: Chronic Heart Failure
Keywords: Serelaxin, Chronic heart failure, Spiroergometry, Troponin, New York Heart Association (NYHA) functional Class II/III, Left ventricular ejection fraction,
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 26
Healthy volunteers: no

Brief summary:
This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.

Detailed description:

Arms:
arm 1: On Day 1 of treatment period 1, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. arm 2: On Day 1 of treatment period 1, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen.

Interventions: intervention 1: Serelaxin intervention 2: Placebo
Intervention descriptions: intervention 1: Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen intervention 2: Matching placebo i.v infusion

Protocol document: