Swiss-based Vifor Pharma has initiated three clinical trials known as AFFIRM-AHF, FAIR-HF2 and HEART-FID, to assess the efficacy of Ferinject on morbidity and mortality outcomes in systolic heart failure and iron deficiency patients.
Ferinject is a non-dextran-based intravenous (IV) iron replacement therapy with ferric carboxymaltose as the active pharmaceutical ingredient.
The trials are designed to support the positive findings from the previous FAIR-HF, CONFIRM-HF and EFFECT-HF trials that demonstrated statistically significant benefits of Ferinject in relation to symptoms, functional capacity and oxygen consumption.
The AFFIRM-AHF trial is set to be conducted in 1,100 acute heart failure patients and will involve administration of Ferinject or placebo prior to the discharge of patients from hospital after an episode of acute heart failure.
The trial will monitor repeat hospitalisation rate and death as the primary endpoint.
CONFIRM-HF and AFFIRM-AHF principle investigator professor Piotr Ponikowski said: "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."
Funded by Germany’s University Medical Centre Hamburg-Eppendorf (UKE), the FAIR-HF2 trial will evaluate Ferinject in 1,200 systolic CHF and iron deficiency subjects, with recurrent heart failure hospitalisation rate and cardiovascular death being the primary endpoint.
The HEART-FID trial is designed to investigate the effect of Ferinject on 12-month rate of death, hospitalisation for worsening heart failure and the six-month change in a six-minute walk for patients in heart failure with iron deficiency.
The trial will be conducted by the firm’s US partner American Regent in 3,000 adults across North America.