NCT02064868

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

A Multicenter, Prospective, Randomized, Open-label Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,666 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Acute Heart Failure (AHF)

Interventions

Type	Name	Description
DRUG	Serelaxin	30 µg/kg/day IV infusion
DRUG	Standard of Care	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.

Timeline

• Start date: 2014-01-31
• Primary completion: 2017-03-26
• Completion: 2017-04-25
• First posted: 2014-02-17
• Last updated: 2019-03-22
• Results posted: 2019-03-22

Locations

357 sites across 25 countries: Austria, Belgium, Bulgaria, Croatia, Czechia, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Switzerland, United Kingdom