Intravenous Iron in Patients with Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality

Last updated: January 23, 2025
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Completed

Phase

4

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

Iron

Saline

Clinical Study ID

NCT03036462
FAIR-HF2
FAIR-HF2-DZHK5
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with chronic HFrEF (CHF) of at least 3 months duration and a history ofdocumented LVEF<45%.

  2. Confirmed presence of ID (ferritin < 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT < 20 %)

  3. Serum haemoglobin of 9.5 - 14.0 g/dL

  4. At time of screening considered re-stabilised and planned for discharge within next 24 h (NYHA 2 or 3), or stable ambulatory with a HF hospitalisation in the past 12months (NYHA 2-4), or stable ambulatory with BNP > 100 pg/mL or NT-proBNP > 300pg/mL or MR-proANP > 120 pmol/L (NYHA 2-4)

  5. Written informed consent

Exclusion

Exclusion Criteria:

  1. Hypersensitivity to the active substance, to FCM or any of its excipients

  2. Known serious hypersensitivity to other parenteral iron products

  3. Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia

  4. Evidence of iron overload or disturbances in the utilisation of iron

  5. History of severe asthma with known FEV1 <50%

  6. Acute bacterial infection

  7. Presence of a deficiency for vitamin B12 and/or serum folate (if present, this needsto be corrected first)

  8. Use of renal replacement therapy

  9. Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or ablood transfusion in the previous 6 weeks prior to randomisation.

  10. More than 500 meters in the initial 6-minutes walking-test

Study Design

Total Participants: 1105
Treatment Group(s): 2
Primary Treatment: Iron
Phase: 4
Study Start date:
March 07, 2017
Estimated Completion Date:
May 02, 2024

Study Description

The clinical trial is designed as an international, prospective, multi-centre, double-blind, parallel group, randomised, controlled, interventional trial to investigate whether a long-term therapy with i.v. iron (ferric carboxymaltosis) compared to placebo can extend the time-to-first-event of heart failure hospitalisations and cardiovascular (CV) death (in the full population and in the population of patients with TSAT<20%) and reduce the rate of recurrent events of heart failure hospitalisations.

I.v. iron administration in the form of ferric carboxymaltosis (FCM) will be carried out according to the Summary of Product Characteristics (SmPC). Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg FCM at every 4 months, except when haemoglobin is > 16.0 g/dL or ferritin is > 800 µg/L.

In the verum group, all patients will receive a saline administration, when no iron is indicated at the time of the visit and according to the values listed above. Patients originally assigned to the placebo group will receive a saline administration at all visits.

In the control group i.v. NaCl at a volume according to the dosing rules for FCM at all visits will be administered in a double-blind manner.

Connect with a study center

  • SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald

    Bad Friedrichshall, 74177
    Germany

    Site Not Available

  • Kerckhoff Klinik Bad Nauheim

    Bad Nauheim, 61231
    Germany

    Site Not Available

  • Charité Berlin (Campus Virchow-Klinikum)

    Berlin, 13353
    Germany

    Site Not Available

  • Studienzentrum Rankestrasse

    Berlin, 10789
    Germany

    Site Not Available

  • Universitätsmedizin Berlin Campus Benjamin Franklin

    Berlin, 12203
    Germany

    Site Not Available

  • Stiftung Bremer Herzen Bremer Institut für Herz- und Kreislauf- Forschung

    Bremen, 28277
    Germany

    Site Not Available

  • Herzzentrum Dresden, Universitätsklinik

    Dresden, 01307
    Germany

    Site Not Available

  • Uniklinik Greifswald, Klinik und Poliklinik für Innere Medizin B

    Greifswald, 17475
    Germany

    Site Not Available

  • Universitätsmedizin Göttingen

    Göttingen, 37075
    Germany

    Site Not Available

  • Universitätsklinikum Halle (Saale)

    Halle, 06120
    Germany

    Site Not Available

  • Cardiologicum Hamburg

    Hamburg, 22041
    Germany

    Site Not Available

  • Universitärsklinikum Hamburg-Eppendorf

    Hamburg, 20251
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • Universitätsklinikum des Saarlandes

    Homburg, 66421
    Germany

    Site Not Available

  • Universitätsklinikum Jena, Kardiologie

    Jena, 07747
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck

    Lübeck, 23538
    Germany

    Site Not Available

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Universitätsmedizin Mannheim

    Mannheim, 68167
    Germany

    Site Not Available

  • Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie

    Mönchengladbach, 41063
    Germany

    Site Not Available

  • Praxis Dr. Schön Mühldorf

    Mühldorf, 84453
    Germany

    Site Not Available

  • Klinikum rechts der Isar I. Medizinische Klinik und Poliklinik

    München, 81675
    Germany

    Site Not Available

  • LMU München Medizinische Klinik und Poliklinik 1

    München, 81377
    Germany

    Site Not Available

  • Gemeinschaftspraxis Hagenmiller/ Jeserich

    Nürnberg, 90402
    Germany

    Site Not Available

  • Universitätsklinik Medizinische Klinik 8 - Kardiologie Paracelsus Medizinische Privatuniversität Klinikum Nürnberg, Campus Süd

    Nürnberg, 90471
    Germany

    Site Not Available

  • KardioPrax Remscheid

    Remscheid, 42853
    Germany

    Site Not Available

  • Kardiologische Praxis Dr. Jens Placke

    Rostock, 18059
    Germany

    Site Not Available

  • Studienzentrum Herzklinik Ulm GbR

    Ulm, 89077
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Evangelisches Klinikum Witten

    Witten, 58455
    Germany

    Site Not Available

  • Honvéd Kórház

    Budapest, 1134
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1122
    Hungary

    Site Not Available

  • Szent Imre Kórház

    Budapest, 1115
    Hungary

    Site Not Available

  • Szent János kórház és Észak-budai Egyesített kórházak

    Budapest, 1125
    Hungary

    Site Not Available

  • Pécsi Orvostudományi

    Pecs, 7624
    Hungary

    Site Not Available

  • Almási Balogh Pál Kórház

    Ózd, 3600
    Hungary

    Site Not Available

  • IRCCS San Raffaele Pisana (06-01)

    Rome, 00163
    Italy

    Site Not Available

  • Cermed Hernik (05-07)

    Białystok, 15-270
    Poland

    Site Not Available

  • Oddział Kardiologii Uniwersyteckiego (05-06)

    Opole, 45-401
    Poland

    Site Not Available

  • Klinika Niewydolności Serca I Transplantologii (05-04)

    Warsaw, 04-743
    Poland

    Site Not Available

  • Wroclaw Medical University (05-01)

    Warschau, 50-981
    Poland

    Site Not Available

  • KLIMED Marek Klimkiewicz Lomza (05-05)

    Łomża, 18-404
    Poland

    Site Not Available

  • Hospital de la Luz

    Lisbon, 1500-650
    Portugal

    Site Not Available

  • Santa Maria University Hospital

    Lisbon, 1649-028
    Portugal

    Site Not Available

  • Clinical Center of Serbia, Department of Cardiology

    Belgrad, 11000
    Serbia

    Site Not Available

  • Clinical Hospital Center Zvezdara

    Belgrad, 11000
    Serbia

    Site Not Available

  • Institute of Cardiovascular Diseases "Dedinje"

    Belgrad, 11040
    Serbia

    Site Not Available

  • Clinical Hospital Center Zemun

    Belgrade, 11080
    Serbia

    Site Not Available

  • General Hospital "Sveti Luka"

    Smederevo, 11300
    Serbia

    Site Not Available

  • Institute for Cardiovascular Diseases of Vojvodina

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • University Medical Centre Ljubljana (07-03)

    Ljubljana, 1000
    Slovenia

    Site Not Available

  • General Hospital Murska Sobota Division of Cardiology (07-01)

    Murska Sobota, 9000
    Slovenia

    Site Not Available

  • Hospital Topolšica (07-03)

    Topolšica, SI-3326
    Slovenia

    Site Not Available

  • Hospital del Mar (04-01)

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital Universitario Clinico San Carlos Madrid (04-04)

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitarion Virgen de la Victoria (04-03)

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Clinico Universitario Valencia (04-02)

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital la Fe de Valencia (04-05)

    Valencia, 46026
    Spain

    Site Not Available

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