Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure

Key Inclusion criteria:

Body weight ≥2.5 kg to ≤120 kg
Hospitalized in an intensive care unit or step-down unit with the following:
- Signs and symptoms of acute heart failure of any etiology
- Stable dose of vasoactive and/or inotropic drugs
- For non-surgical patients echocardiographic evidence of reduced ventricular function (ejection fraction <50% or fractional shortening <28%)
Systolic blood pressure (SBP) ≥25th percentile SBP for age and gender.

Key Exclusion criteria:

Moderate to severe left ventricular outflow tract, mitral stenosis, or aortic arch obstruction
Single ventricle physiology
Fixed pulmonary hypertension
Blood lactate levels >5 mmol/L at screening
Birth < 36 weeks post-conceptual age (for patients <1year old)
Confirmed or clinically suspected systemic infection or severe localized infection
Dyspnea or acute lung injury primarily due to non-cardiac causes
Patients with severe renal impairment, those known to have significant renal disease and those having renal replacement therapy
High use of inotropic and/or vasoactive agents at screening
Electrocardiographic abnormalities
Solid organ transplant recipient within 1 year of transplantation or one who presents with severe organ rejection