Pharmacosmos’ initiates first hard endpoint randomised controlled trial looking at the effect of intravenous (IV) iron in chronic heart failure (CHF)
The ‘Effectiveness of intravenous iron treatment vs standard care in patients with heart failure and iron deficiency: a randomised, open-label multicentre trial (IRONMAN)’ is the first to examine the effects of IV iron as Monofer (iron isomaltoside) directly on cardiovascular mortality and hospitalisation in patients with CHF, according to Pharmacosmos.
The study will be the largest and longest running study conducted in patients with iron deficiency and CHF due to left ventricular (LV) systolic dysfunction, the company said.
A total of 1,300 patients will be enrolled in the study via multiple sites across the UK. This makes IRONMAN both the largest randomised controlled trial of IV iron in CHF and according to Pharmacosmos, the largest trial ever made comparing IV iron to a comparator that is not IV iron.
Patients in the trial will be randomised to either Monofer or standard therapy not allowing for IV iron.
Several studies with different IV iron preparations have shown a consistent picture of symptom improvement in iron deficient CHF patients in response to IV iron treatment independently of whether the patients were anaemic or not.
However, Pharmacosmos said so far no studies have been powered to evaluate the impact on ‘hard endpoints’ such as cardiovascular death or hospitalisation. IRONMAN has been designed specifically to evaluate the impact of IV iron onthese hard points in patients with CHF.
Chief investigator Paul Kalra, consultant cardiologist, Portsmouth Hospitals NHS Trust and honorary senior lecturer, University of Glasgow, said: “This is a landmark study that will change clinical practice by determining the role for IV iron in CHF.
“If positive, the study will help improve the prognosis for patients with heart failure and demonstrate the potential for IV iron to impact outcomes independently of haemoglobin.”
The IRONMAN trial has been approved by UK Ethics Committee and the Medicines and Healthcare Products Regulatory Authority (MHRA) and is now ready to include patients.