Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure

Key Inclusion Criteria:

Body weight of ≤ 160 kg.
Subjects with compensated CHF (NYHA Class II - III) at time of screening with a prior documented history of chronic heart failure.
NT-proBNP >300 pg/ml (according to central measurement) at visit 1.
Subjects treated with appropriate and guideline-indicated CHF standard of care.
Ability to comply with all requirements, including ability to receive at least a 48 hour infusion plus follow-up time required for each dosing visit.

Key Exclusion Criteria:

Current acute decompensated HF
Any major solid organ transplant recipient or planned anticipated organ transplant within 1 year.
Documented history of untreated ventricular arrhythmia with syncopal episodes, ventricular tachycardia, or ventricular fibrillation without ICD (implantable cardioverter defibrillator) with significant hemodynamic consequences within the 3 months prior to screening.
Presence of hemodynamically significant mitral and /or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation: including significant left ventricular outflow obstruction (e.g., obstructive hypertrophic cardiomyopathy, severe aortic stenosis)
Subjects with severe renal impairment defined as pre-randomization eGFR < 30 ml/min/1.73m2 calculated using the sMDRD equation and/or those receiving current or planned dialysis or ultrafiltration