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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic heart failure.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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