Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure (RELAX-REPEAT)

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Heart Failure

Treatments: Drug: RLX030 (serelaxin); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01982292

CRLX030A2209

2013-002781-39 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 321 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

321 participants in 2 patient groups, including a placebo group

RLX030 (serelaxin)

Experimental group

Description:

Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8

Treatment:

Drug: RLX030 (serelaxin)

Placebo

Placebo Comparator group

Description:

Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8

Treatment:

Drug: Placebo