Phase
Condition
Chest Pain
Congestive Heart Failure
Heart Failure
Treatment
Iron
Saline
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with chronic HFrEF (CHF) of at least 3 months duration and a history ofdocumented LVEF<45%.
Confirmed presence of ID (ferritin < 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT < 20 %)
Serum haemoglobin of 9.5 - 14.0 g/dL
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)
Written informed consent
Exclusion
Exclusion Criteria:
Hypersensitivity to the active substance, to FCM or any of its excipients
Known serious hypersensitivity to other parenteral iron products
Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia
Evidence of iron overload or disturbances in the utilisation of iron
History of severe asthma with known FEV1 <50%
Acute bacterial infection
Presence of a deficiency for vitamin B12 and/or serum folate (if present, this needsto be corrected first)
Use of renal replacement therapy
Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or ablood transfusion in the previous 6 weeks prior to randomisation.
More than 500 meters in the initial 6-minutes walking-test
Study Design
Study Description
Connect with a study center
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
Bad Friedrichshall, 74177
GermanySite Not Available
Kerckhoff Klinik Bad Nauheim
Bad Nauheim, 61231
GermanySite Not Available
Charité Berlin (Campus Virchow-Klinikum)
Berlin, 13353
GermanySite Not Available
Studienzentrum Rankestrasse
Berlin, 10789
GermanySite Not Available
Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin, 12203
GermanySite Not Available
Stiftung Bremer Herzen Bremer Institut für Herz- und Kreislauf- Forschung
Bremen, 28277
GermanySite Not Available
Herzzentrum Dresden, Universitätsklinik
Dresden, 01307
GermanySite Not Available
Uniklinik Greifswald, Klinik und Poliklinik für Innere Medizin B
Greifswald, 17475
GermanySite Not Available
Universitätsmedizin Göttingen
Göttingen, 37075
GermanySite Not Available
Universitätsklinikum Halle (Saale)
Halle, 06120
GermanySite Not Available
Cardiologicum Hamburg
Hamburg, 22041
GermanySite Not Available
Universitärsklinikum Hamburg-Eppendorf
Hamburg, 20251
GermanySite Not Available
Universitätsklinikum Heidelberg
Heidelberg, 69120
GermanySite Not Available
Universitätsklinikum des Saarlandes
Homburg, 66421
GermanySite Not Available
Universitätsklinikum Jena, Kardiologie
Jena, 07747
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, 23538
GermanySite Not Available
Universitätsklinikum Magdeburg
Magdeburg, 39120
GermanySite Not Available
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
GermanySite Not Available
Universitätsmedizin Mannheim
Mannheim, 68167
GermanySite Not Available
Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie
Mönchengladbach, 41063
GermanySite Not Available
Praxis Dr. Schön Mühldorf
Mühldorf, 84453
GermanySite Not Available
Klinikum rechts der Isar I. Medizinische Klinik und Poliklinik
München, 81675
GermanySite Not Available
LMU München Medizinische Klinik und Poliklinik 1
München, 81377
GermanySite Not Available
Gemeinschaftspraxis Hagenmiller/ Jeserich
Nürnberg, 90402
GermanySite Not Available
Universitätsklinik Medizinische Klinik 8 - Kardiologie Paracelsus Medizinische Privatuniversität Klinikum Nürnberg, Campus Süd
Nürnberg, 90471
GermanySite Not Available
KardioPrax Remscheid
Remscheid, 42853
GermanySite Not Available
Kardiologische Praxis Dr. Jens Placke
Rostock, 18059
GermanySite Not Available
Studienzentrum Herzklinik Ulm GbR
Ulm, 89077
GermanySite Not Available
Universitätsklinikum Ulm
Ulm, 89081
GermanySite Not Available
Evangelisches Klinikum Witten
Witten, 58455
GermanySite Not Available
Honvéd Kórház
Budapest, 1134
HungarySite Not Available
Semmelweis Egyetem
Budapest, 1122
HungarySite Not Available
Szent Imre Kórház
Budapest, 1115
HungarySite Not Available
Szent János kórház és Észak-budai Egyesített kórházak
Budapest, 1125
HungarySite Not Available
Pécsi Orvostudományi
Pecs, 7624
HungarySite Not Available
Almási Balogh Pál Kórház
Ózd, 3600
HungarySite Not Available
IRCCS San Raffaele Pisana (06-01)
Rome, 00163
ItalySite Not Available
Cermed Hernik (05-07)
Białystok, 15-270
PolandSite Not Available
Oddział Kardiologii Uniwersyteckiego (05-06)
Opole, 45-401
PolandSite Not Available
Klinika Niewydolności Serca I Transplantologii (05-04)
Warsaw, 04-743
PolandSite Not Available
Wroclaw Medical University (05-01)
Warschau, 50-981
PolandSite Not Available
KLIMED Marek Klimkiewicz Lomza (05-05)
Łomża, 18-404
PolandSite Not Available
Hospital de la Luz
Lisbon, 1500-650
PortugalSite Not Available
Santa Maria University Hospital
Lisbon, 1649-028
PortugalSite Not Available
Clinical Center of Serbia, Department of Cardiology
Belgrad, 11000
SerbiaSite Not Available
Clinical Hospital Center Zvezdara
Belgrad, 11000
SerbiaSite Not Available
Institute of Cardiovascular Diseases "Dedinje"
Belgrad, 11040
SerbiaSite Not Available
Clinical Hospital Center Zemun
Belgrade, 11080
SerbiaSite Not Available
General Hospital "Sveti Luka"
Smederevo, 11300
SerbiaSite Not Available
Institute for Cardiovascular Diseases of Vojvodina
Sremska Kamenica, 21204
SerbiaSite Not Available
University Medical Centre Ljubljana (07-03)
Ljubljana, 1000
SloveniaSite Not Available
General Hospital Murska Sobota Division of Cardiology (07-01)
Murska Sobota, 9000
SloveniaSite Not Available
Hospital Topolšica (07-03)
Topolšica, SI-3326
SloveniaSite Not Available
Hospital del Mar (04-01)
Barcelona, 08003
SpainSite Not Available
Hospital Universitario Clinico San Carlos Madrid (04-04)
Madrid, 28040
SpainSite Not Available
Hospital Universitarion Virgen de la Victoria (04-03)
Málaga, 29010
SpainSite Not Available
Hospital Clinico Universitario Valencia (04-02)
Valencia, 46010
SpainSite Not Available
Hospital la Fe de Valencia (04-05)
Valencia, 46026
SpainSite Not Available
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