Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients (RELAX-AHF-EU)

Novartis

Status and phase: Terminated; Phase 3

Conditions: Acute Heart Failure (AHF)

Treatments: Drug: Standard of Care; Drug: Serelaxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02064868

CRLX030A3301

2013-002513-35 (EudraCT Number)

Details and patient eligibility

About

This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).

Full description

This study was aimed at generating clinical evidence, especially on the short term period (in-hospital and at 30 days) to complement existing and future serelaxin data sets in Acute Heart Failure (AHF).

Enrollment: 2,666 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Systolic blood pressure ≥ 125 mmHg
• Admitted for Acute Heart Failure (AHF)
• Received intravenous furosemide (or equivalent) at any time between presentation and the start of screening
• eGFR on admission: ≥ 25 and ≤75 mL/min/1.73 m^2

Exclusion criteria

• Dyspnea (non-cardiac causes)
• T > 38.5°C
• Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
• Significant left ventricular outflow obstruction, uncorrected, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm^2 or mean gradient >50 mmHg on prior or current echocardiogram), severe aortic regurgitation and severe mitral stenosis.
• AHF due to significant arrhythmias
• Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,666 participants in 2 patient groups

Serelaxin + Standard of Care

Experimental group

Description:

Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.

Treatment:

Drug: Serelaxin

Drug: Standard of Care

Standard of Care (SOC)

Other group

Description:

All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Treatment:

Drug: Standard of Care