Ferinject® for iron deficiency in IPAH patients

• Research type

  Research Study

• Full title

  What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?

• IRAS ID

  54579

• Contact name

  Luke Howard

• Sponsor organisation

  Imperial College Academic Healthsciences Centre

• Eudract number

  2010-024585-22

• ISRCTN Number

  ISRCTN

• Research summary

  Pulmonary arterial hypertension (PAH) means high blood pressure in blood vessels (arteries) in the lungs, due to their constriction and occlusion. This forces the heart to work harder in pumping blood through the lungs, and eventually, the heart fails. It is a relatively rare but serious disease; with untreated patients surviving on average 3 years. In the last 10 years new treatments have become available but survival remains unacceptably poor, with around one-third of patients dying within 2 years from their diagnosis. New treatments are needed. We have shown that up to two-thirds of patients with idiopathic PAH (IPAH, with unknown cause) are iron deficient (do not have enough iron). PAH patients with iron deficiency will on average survive less than patients with normal amounts of iron. We can test for iron deficiency with standard hospital blood tests and patients identified as iron deficient would normally be prescribed oral iron tablets. However, this is slow to take effect, iron uptake from the intestine may be actively inhibited in IPAH patients and people often do not take the tablets as they can have unpleasant side-effects on the digestive system. The alternative we want to investigate is the direct intravenous infusion of iron into the blood of patients. This will quickly replace the iron that is lacking from our patients. Ferric carboxymaltose is a drug that contains iron and can be injected in large quantities safely. In a recent study of several hundred patients with heart failure, the injection of ferric carboxymaltose improved how they felt and how far they could walk 3 months later. We propose to study the effects of ferric carboxymaltose infusion in iron deficient patients with IPAH and measure its effect on blood pressure in the lungs over a similar period of time.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/LO/0095

• Date of REC Opinion

  4 Mar 2011

• REC opinion

  Favourable Opinion