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

• Status: Terminated
• Trial end date: 2017-04-03
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (AHF)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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