Human Relaxin RLX.CHF.003 Acute Heart Failure Amendment 2

• Research type

  Research Study

• Full title

  A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure

• IRAS ID

  18193

• Sponsor organisation

  Corthera, Inc.

• Eudract number

  2007-004271-19

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT00520806

• Research summary

  The purpose of this study is to evaluate the safety and effectiveness of relaxin in patients with acute heart failure (AHF) who have normal to high blood pressure and decreased kidney function.Participants will be randomised 1:1 to receive standard AHF therapy plus relaxin or standard AHF therapy plus the placebo, within 16 hours of arriving at the emergency department or hospital.Eligible participants hospitalised with AHF will have the study drug (relaxin or placebo) administered as soon as possible after randomisation, by intravenous infusion for 48 hours. A dose level of 30 æg/kg/day of relaxin was selected based on safety and efficacy results of the Pre-RELAX-AHF phase of this study.Patients will be evaluated for symptoms and signs of heart failure at screening and Baseline, at 6, 12 and 24 hours, daily while hospitalised up to Day 4, and at Days 5, 14 and 60. Blood and urine samples will be collected at baseline and at 24 and 48 hours for routine safety assessments and to evaluate renal function. Further blood samples will be collected on Days 3, 4, 5, 14 and 60. All patients will be contacted by phone at Day 180 to ascertain vital status. Corthera, Inc. provides financial support for this study. This also covers the cost of the study staff in the hospital to run the trial and collect data.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  09/H1307/62

• Date of REC Opinion

  25 Sep 2009

• REC opinion

  Further Information Favourable Opinion