FAIR-HF2-DZHK5


Study information
FAIR-HF2-DZHK5

Recruiting status

Recruiting ongoing

Recruitment start

03/2017

Patients

532

1200

Clinical Trials Registration

NCT03036462

Category

Guideline relevant study

DZHK Funding

EUR 6.578.978,32

Links

https://fair-hf2.dzhk.de/

Operative contact
Main study centre - Mahir Karakas, MD
fair-hf2@dzhk.de

Studienzentren/Kontakt (PDF)

Intravenous iron in patients with systolic heart failure and iron deficiency to improve morbidity and mortality (FAIR-HF2-DZHK5)

Various studies claim that iron deficiency is a co-morbidity in 35 to 60 percent of patients suffering from heart failure. Iron deficiency causes two problems: on the one hand, iron is essential for providing the cells of the body with energy, while on the other hand the blood cells are unable to transport sufficient oxygen. This results in tiredness, a drop in performance and disturbed concentration. On the whole, the body is more susceptible to diseases.

The FAIR-HF2 study will be assessing whether treatment with intravenously administered ferric carboxymaltose improves the chances of survival and helps to reduce the number of hospitalisations of heart failure patients diagnosed with iron deficiency. Previous studies have already demonstrated that the symptoms of heart failure and the quality of life of iron deficiency patients can be improved by correcting the iron deficiency. The findings also suggest that this therapy decreases the frequency of hospital stays related to heart failure. However, this will be studied systematically in a randomised, placebo-controlled study design.

1,200 patients diagnosed with at least moderate heart failure are to be enrolled. Within this study the patients will be divided into two groups. The first group will receive regular ferric carboxymaltose infusions, while the second group will receive saline infusions. The infusions are very well tolerated and the iron contained therein is rapidly absorbed by the body. Ferric carboxymaltose is a so-called high-dose preparation. The reason why the researches chose this preparation is that two infusions at most are sufficient to completely replenish the iron stores. The researchers are expecting to see a class effect; this means that the results can probably be transferred to other intravenously administered iron preparations.

Should the findings confirm the hypothesis that iron therapy increases the survival of heart failure patients and reduces the number of hospital stays, this result will be incorporated in the therapy guidelines. If this is the case, every patient suffering from heart failure and iron deficiency should receive an appropriate intravenous therapy, which has not necessarily been the case until now. For many heart failure patients, this would considerably improve their prognosis.

Please use the following link to get to the website of the study https://fair-hf2.dzhk.de/

Publications

Effect of ferric carboxymaltose on calculated plasma volume status and clinical congestion: a FAIR-HF substudy. Okonko, D. O., Jouhra, F., Abu-Own, H., Filippatos, G., Colet, J. C., Suki, C., Mori, C., Ponikowski, P., Anker, S. D. & Investigators, F.-H. ESC heart failure. (2019)

The impact of intravenous ferric carboxymaltose on renal function: an analysis of the FAIR-HF study. Ponikowski P, Filippatos G, Colet JC, Willenheimer R, Dickstein K, Lüscher T, Gaudesius G, von Eisenhart Rothe B, Mori C, Greenlaw N, Ford I, Macdougall I, Anker SD; FAIR-HF Trial Investigators. Eur J Heart Fail. 2015 Mar;17(3):329-39.

Principal Investigators

Dr. med. Mahir Karakas
Universitäres Herzzentrum Hamburg
Prof. Dr. Stefan Anker
Charité - Universitätsmedizin Berlin (Campus Virchow-Klinikum)
Göttingen,Hamburg,Berlin,Lübeck,Kiel,Magdeburg,Mainz,Bad Nauheim,Homburg,Mannheim,Heidelberg,Ulm,Nürnberg,Jena,Greifswald,Rostock,Bremen,Mönchengladbach,Remscheid,München,Mühldorf,Bad Friedrichshall,Dresden,Halle (Saale),Burg

Study recruitment is available in these cities