Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
The purpose of this study was to assess the safety of repeat doses of serelaxin in 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