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

• Status: Terminated
• Trial end date: 2017-04-25
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Mineralocorticoid Receptor Antagonists

Criteria

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).