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

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.

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

Other protocol defined inclusion/exclusion criteria may apply.