As part of its continued commitment to improving the lives of patients suffering from heart failure and iron deficiency, Vifor Pharma announces three recently-initiated double-blind, placebo-controlled clinical trials, entitled AFFIRM-AHF, FAIR-HF2 and HEART-FID, which will study the effects of Ferinject® (ferric carboxymaltose) versus placebo on morbidity and mortality outcomes.
These trials follow the FAIR-HF1, CONFIRM-HF2 and EFFECT-HF3 trials, which showed statistically significantly beneficial effects of Ferinject® versus placebo or standard of care, on symptoms, functional capacity and oxygen consumption, respectively. Consideration of Ferinject® is now recommended in the European Society of Cardiology (ESC) Heart Failure 2016 Guidelines4 for the treatment of symptomatic patients with systolic chronic heart failure (CHF) and iron deficiency. Ferinject® is the only intravenous (i.v.) iron treatment specifically mentioned in the ESC guidelines. Recently the American College of Cardiology/American Heart Association/Heart Failure Society of America (ACC/AHA/HFSA) issued a focused update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure (HF). This recent ACCF/AHA update included a new recommendation that intravenous repletion of iron, especially in the setting of concomitant hepcidin deficiency in HF, may improve exercise capacity and quality of life (QoL). Furthermore, the European Medical Agency approved in March 2017 the inclusion of the CONFIRM-HF results in the Ferinject® prescribing information.
The AFFIRM-AHF trial is the first study of Ferinject® in the acute heart failure patient population. In this trial, 1,100 patients will be randomised to receive either Ferinject® or placebo before being discharged from the hospital following an episode of acute heart failure. The rate of repeat hospitalisations and death will comprise the primary endpoint.
"We are encouraged by the results of an analysis from the CONFIRM-HF trial which showed a reduction in hospitalisation for worsening heart failure in patients with systolic chronic heart failure and iron deficiency who were treated with Ferinject®. This gives us reason to believe we may also be able to have a positive impact on vulnerable acute heart failure patients with iron deficiency and the AFFIRM-AHF trial sets out to prospectively study this," said Prof Piotr Ponikowski, Head of the Department of Heart Diseases, Wroclaw Medical University and Head of the Cardiology Department at the Center for Heart Diseases at 4th Military Hospital, Wroclaw, Poland, and principle investigator for both the CONFIRM-HF and the AFFIRM-AHF trials.
The FAIR-HF2 trial is an independent study sponsored by the University Medical Center Hamburg-Eppendorf (UKE), within the frame of the German Center for Cardiovascular Disease (DZHK) and in cooperation with the University of Göttingen, and the Charité in Berlin, Germany. In this trial, 1,200 patients with systolic CHF and iron deficiency will be randomised to Ferinject® or placebo. As in the AFFIRM-AHF trial, the rate of recurrent heart failure hospitalisations and cardiovascular death will comprise the primary endpoint.
"The earlier trials, specifically FAIR-HF and CONFIRM-HF, showed us that we can improve both symptoms and functional capacity in our systolic chronic heart failure patients with iron deficiency with Ferinject®. Importantly, a recently published meta-analysis reported significantly lower rates of recurrent cardiovascular hospitalisation and cardiovascular death for patients with iron deficiency and systolic chronic heart failure treated with Ferinject® versus placebo. The FAIR-HF2 trial will explore whether we can further advance the care of these patients by reducing the rate of recurrent hospitalisations for heart failure and death," said Prof Stefan Anker, Division of Cardiology and Metabolism; Department of Internal Medicine & Cardiology; DZHK (German Center for Cardiovascular Research); and Berlin-Brandenburg Center for Regenerative Therapies (BCRT), at Charité University Medicine, Berlin, Germany
The HEART-FID5 trial, conducted by Vifor Pharma's US partner American Regent, a member of the Daiichi Sankyo Group, will assess the effects of Injectafer® (US brand name of Ferinject®) compared to placebo on the following outcome measures: the 12-month rate of death, hospitalisation for worsening heart failure, and the six-month change in six-minute walk for patients in heart failure with iron deficiency. The study is anticipated to enroll more than 3,000 adult patients across North America, and is one of the largest studies of intravenous iron in heart failure.
"Iron deficiency affects up to half of all heart failure patients and is associated with impaired exercise tolerance, and mortality in patients with or without anaemia6," said Prof Adrian F. Hernandez, MD, MHS, Duke Clinical Research Institute, Durham, North Carolina, USA, and HEART-FID study chair. "HEART-FID has the potential to provide a deeper understanding of how intravenous iron may help patients with heart failure with a low ejection fraction."
