drugset / Trial / NCT03036462
Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality
Phase 4
Completed
1105 enrolled
University Medical Center Hamburg-Eppendorf
Charite University, Berlin, Germany · collabDeutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) extends the time-to-first-event of heart failure hospitalisations and cardiovascular (CV) death and reduces hospitalisation and mortality in patients with iron deficiency and heart failure.
Timeline
- Start
- 2017-03-07
- Primary completion
- 2024-05-02
- Completion
- 2024-05-02
Publications
- Karakas M, Friede T, Butler J, Talha KM, Placzek M, Asendorf T, Diek M, Nosko A, Stas A, Kluge S, Jarczak D, DeHeer G, Rybczynski M, Bayes-Genis A, Bohm M, Coats AJS, Edelmann F, Filippatos G, Hasenfuss G, Haverkamp W, Lainscak M, Landmesser U, Macdougall IC, Merkely B, Pieske BM, Pinto FJ, Rassaf T, Visser-Rogers JK, Rosano G, Volterrani M, von Haehling S, Anker MS, Doehner W, Ince H, Koehler F, Savarese G, Khan MS, Krohnert UR, Gori T, Trenkwalder T, Akin I, Paitazoglou C, Kobielusz-Gembala I, Kuthi L, Frey N, Licka M, Kaab S, Laugwitz KL, Ponikowski P, Anker SD. Intravenous ferric carboxymaltose in heart failure with iron deficiency (FAIR-HF2 DZHK05 trial): Sex-specific outcomes. Eur J Heart Fail. 2025 Nov;27(11):2328-2342. doi: 10.1002/ejhf.3742. Epub 2025 Jul 31.
- Anker SD, Friede T, Butler J, Talha KM, Placzek M, Diek M, Nosko A, Stas A, Kluge S, Jarczak D, Deheer G, Rybczynski M, Bayes-Genis A, Edelmann F, Filippatos G, Hasenfuss G, Haverkamp W, Lainscak M, Landmesser U, Macdougall IC, Merkely B, Pieske BM, Pinto FJ, Rassaf T, Volterrani M, von Haehling S, Anker MS, Doehner W, Ince H, Koehler F, Savarese G, Rauch-Krohnert U, Gori T, Trenkwalder T, Akin I, Paitazoglou C, Kobielusz-Gembala I, Zmuda W, Kuthi L, Frey N, Licka M, Kaab S, Laugwitz KL, Ponikowski P, Karakas M. Ferric carboxymaltose assessment of morbidity and mortality in patients with iron deficiency and chronic heart failure (FAIR-HF2-DZHK05) trial: Baseline characteristics and comparison to other relevant clinical trials. Eur J Heart Fail. 2025 Aug;27(8):1436-1443. doi: 10.1002/ejhf.3658. Epub 2025 Apr 29.
- Anker SD, Friede T, Butler J, Talha KM, Placzek M, Diek M, Nosko A, Stas A, Kluge S, Jarczak D, deHeer G, Rybczynski M, Bayes-Genis A, Bohm M, Coats AJS, Edelmann F, Filippatos G, Hasenfuss G, Haverkamp W, Lainscak M, Landmesser U, Macdougall IC, Merkely B, Pieske BM, Pinto FJ, Rassaf T, Visser-Rogers JK, Rosano G, Volterrani M, von Haehling S, Anker MS, Doehner W, Ince H, Koehler F, Savarese G, Khan MS, Rauch-Krohnert U, Gori T, Trenkwalder T, Akin I, Paitazoglou C, Kobielusz-Gembala I, Kuthi L, Frey N, Licka M, Kaab S, Laugwitz KL, Ponikowski P, Karakas M. Intravenous Ferric Carboxymaltose in Heart Failure With Iron Deficiency: The FAIR-HF2 DZHK05 Randomized Clinical Trial. JAMA. 2025 Jun 10;333(22):1965-1976. doi: 10.1001/jama.2025.3833.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric carboxymaltose | Other / unclassified | 500 mg | Intravenous |