Globifer Forte in Heart Failure (GLOBIFER-HF)version 01

• Research type

  Research Study

• Full title

  Globifer Forte® Oral Haem and Non-haem Iron Supplementation in Heart Failure: A Randomised, Double-Blind, Placebo-Controlled, Double-Dummy, Part Mechanistic, Phase 4 Trial.

• IRAS ID

  139202

• Contact name

  Darlington Okonko

• Contact email

  darlington.okonko@kcl.ac.uk

• Sponsor organisation

  King's College London

• Eudract number

  2013-004704-19

• Research summary

  Iron deficiency is common in patients with heart failure and worsens breathlesness and exercise capacity. Correcting iron deficiency with intravenous iron improves symptoms and exercise in heart failure patients but intravenous iron is more expensive than oral iron preparations. Oral iron can be absorbed in the gut as a free molecule (non-haem iron) or bound to haemoglobin (haem iron) and tablets for each type of oral iron exists. There is evidence that haem iron is more easily absorbed than non-haem iron.

  In the GLOBIFER-HF study we wish to determine whether iron levels and exercise capacity are best improved with non-haem (=ferrous sulphate) or haem (= Globifer Forte®) iron tablets in heart failure patients. We will randomise 60 iron deficient heart failure patients to 12 weeks of ferrous sulphate (n=24), Globifer Forte® (n=24), or placebo (n=12) tablets.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  14/LO/1158

• Date of REC Opinion

  28 Jan 2015

• REC opinion

  Further Information Favourable Opinion