Affirm-AHF

• Research type

  Research Study

• Full title

  A Randomised, Double-blind Placebo Controlled Trial Comparing the Effect of Intravenous Ferric Carboxymaltose on Hospitalisations and Mortality in Iron Deficient Patients Admitted for Acute Heart Failure (Affirm-AHF)

• IRAS ID

  217054

• Contact name

  Khalid Farrag

• Contact email

  khalid.farrag@viforpharma.com

• Sponsor organisation

  Vifor (International) Inc.

• Eudract number

  2016-001467-36

• Clinicaltrials.gov Identifier

  NCT02937454

• Duration of Study in the UK

  2 years, 3 months, 0 days

• Research summary

  The medication being tested is ferric carboxymaltose (FCM), which is an iron therapy, registered and approved for treating iron deficiency in over 60 countries. The affects of FCM are being compared to those of a placebo. The purpose of this study is to look at whether correcting iron deficiency when hospitalised for acute decompensated heart failure my improve symptoms and well-being. About 650 participants from about 135 centres around the world will be joining in this study. Subject participation will last for up to 52 weeks.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  16/LO/2153

• Date of REC Opinion

  27 Jan 2017

• REC opinion

  Further Information Favourable Opinion