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FAIR-HF2: Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Recruiting
CT.gov ID
NCT03036462
Collaborator
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) (Other), Charite University, Berlin, Germany (Other)
1,200
Enrollment
58
Locations
2
Arms
86.7
Anticipated Duration (Months)
20.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) reduces hospitalisation and mortality in patients with iron deficiency and heart failure.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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 reduce the rate of recurrent heart failure hospitalisations and cardiovascular (CV) death in patients with heart failure with reduced ejection fraction (HFrEF).

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality - FAIR-HF2
Actual Study Start Date :
Feb 7, 2017
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Verum group (FCM)

I.v. iron administration in the form of FCM will be carried out according to SmPC. I.v. iron 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 the 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.

Drug: Iron
i.v. iron administration
Placebo Comparator: Placebo group (NaCL)

Administration of i.v. NaCl at a volume according to the dosing rules for FCM, i.e. as described for the verum group.

Drug: Saline
i.v. NaCl administration
Other Names:
  • salin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Combined rate of recurrent hospitalisations for heart failure (HF) and of cardiovascular death (number of events) [at least after 12 month of follow-up]

      Combined rate of recurrent hospitalisations for heart failure and of cardiovascular death during follow-up.

    Secondary Outcome Measures

    1. Combined rate of recurrent cardiovascular hospitalisations and of cardiovascular death (number of events) [at least after 12 month of follow-up]

      Combined rate of recurrent cardiovascular hospitalisations and of cardiovascular death during follow-up

    2. Combined rate of recurrent hospitalisations for any reason and of cardiovascular death (number of events) [at least after 12 month of follow-up]

      Combined rate of recurrent hospitalisations for any reason and of cardiovascular death during follow-up

    3. Rate of recurrent cardiovascular hospitalisations (number of events) [at least after 12 month of follow-up]

      Rate of recurrent cardiovascular hospitalisations during follow-up

    4. Rate of recurrent HF hospitalisations (number of events) [at least after 12 month of follow-up]

      Rate of recurrent HF hospitalisations during follow-up

    5. Rate of recurrent hospitalisations of any kind (number of events) [at least after 12 month of follow-up]

      Rate of recurrent hospitalisations of any kind during follow-up

    6. All-cause mortality (number of events) [at least after 12 month of follow-up]

      All-cause mortality during follow-up

    7. cardiovascular mortality (number of events) [at least after 12 month of follow-up]

      cardiovascular mortality during follow-up

    8. Changes in NYHA (New York Heart Association) functional class (scale) [at least after 12 month of follow-up]

      Changes in NYHA functional class during follow-up

    9. Changes in 6-minute walk-test (nomogram) [at least after 12 month of follow-up]

      Changes in 6-minute walk-test during follow-up

    10. Changes in EQ-5D (questionnaire) [at least after 12 month of follow-up]

      Changes EQ-5D during follow-up

    11. Changes in Patient Global Assessment (PGA) of wellbeing (questionnaire) [at least after 12 month of follow-up]

      Changes in PGA of wellbeing during follow-up

    12. Changes in renal parameters (laboratory parameters) [at least after 12 month of follow-up]

      Changes in renal from baseline to end of follow-up

    13. Changes in cardiovascular parameters (laboratory parameters) [at least after 12 month of follow-up]

      Changes in cardiovascular parameters from baseline to end of follow-up

    14. Changes in inflammatory parameters (laboratory parameters) [at least after 12 month of follow-up]

      Changes in inflammatory parameters from baseline to end of follow-up

    15. Changes in metabolic parameters (laboratory parameters) [at least after 12 month of follow-up]

      Changes in metabolic parameters from baseline to end of follow-up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients aged at least 18 years

    • Patients with chronic heart failure present for at least 12 months

    • Confirmed presence of iron deficiency

    • Serum haemoglobin of 9.5 to 14.0 g/dL

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald Bad Friedrichshall Germany 74177
    2 Kerckhoff Klinik Bad Nauheim Bad Nauheim Germany 61231
    3 Studienzentrum Rankestrasse Berlin Germany 10789
    4 Universitätsmedizin Berlin Campus Benjamin Franklin Berlin Germany 12203
    5 Charité Berlin (Campus Virchow-Klinikum) Berlin Germany 13353
    6 Stiftung Bremer Herzen Bremer Institut für Herz- und Kreislauf- Forschung Bremen Germany 28277
    7 Herzzentrum Dresden, Universitätsklinik Dresden Germany 01307
    8 Uniklinik Greifswald, Klinik und Poliklinik für Innere Medizin B Greifswald Germany 17475
    9 Universitätsmedizin Göttingen Göttingen Germany 37075
    10 Universitätsklinikum Halle (Saale) Halle Germany 06120
    11 Universitärsklinikum Hamburg-Eppendorf Hamburg Germany 20251
    12 Cardiologicum Hamburg Hamburg Germany 22041
    13 Universitätsklinikum Heidelberg Heidelberg Germany 69120
    14 Universitätsklinikum des Saarlandes Homburg Germany 66421
    15 Universitätsklinikum Jena, Kardiologie Jena Germany 07747
    16 Universitätsklinikum Schleswig-Holstein Campus Kiel Kiel Germany 24105
    17 Universitätsklinikum Schleswig-Holstein Campus Lübeck Lübeck Germany 23538
    18 Universitätsklinikum Magdeburg Magdeburg Germany 39120
    19 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Germany 55131
    20 Universitätsmedizin Mannheim Mannheim Germany 68167
    21 Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie Mönchengladbach Germany 41063
    22 Praxis Dr. Schön Mühldorf Mühldorf Germany 84453
    23 LMU München Medizinische Klinik und Poliklinik 1 München Germany 81377
    24 Klinikum rechts der Isar I. Medizinische Klinik und Poliklinik München Germany 81675
    25 Gemeinschaftspraxis Hagenmiller/ Jeserich Nürnberg Germany 90402
    26 Universitätsklinik Medizinische Klinik 8 - Kardiologie Paracelsus Medizinische Privatuniversität Klinikum Nürnberg, Campus Süd Nürnberg Germany 90471
    27 KardioPrax Remscheid Remscheid Germany 42853
    28 Kardiologische Praxis Dr. Jens Placke Rostock Germany 18059
    29 Studienzentrum Herzklinik Ulm GbR Ulm Germany 89077
    30 Universitätsklinikum Ulm Ulm Germany 89081
    31 Szent Imre Kórház Budapest Hungary 1115
    32 Semmelweis Egyetem Budapest Hungary 1122
    33 Szent János kórház és Észak-budai Egyesített kórházak Budapest Hungary 1125
    34 Honvéd Kórház Budapest Hungary 1134
    35 Pécsi Orvostudományi Pecs Hungary 7624
    36 Almási Balogh Pál Kórház Ózd Hungary 3600
    37 IRCCS San Raffaele Pisana (06-01) Rome Italy 00163
    38 Cermed Hernik (05-07) Białystok Poland 15-270
    39 Oddział Kardiologii Uniwersyteckiego (05-06) Opole Poland 45-401
    40 Klinika Niewydolności Serca I Transplantologii (05-04) Warsaw Poland 04-743
    41 Wroclaw Medical University (05-01) Warschau Poland 50-981
    42 KLIMED Marek Klimkiewicz Lomza (05-05) Łomża Poland 18-404
    43 Hospital de la Luz Lisbon Portugal 1500-650
    44 Santa Maria University Hospital Lisbon Portugal 1649-028
    45 Clinical Hospital Center Zemun Belgrade Serbia 11080
    46 Clinical Center of Serbia, Department of Cardiology Belgrad Serbia 11000
    47 Clinical Hospital Center Zvezdara Belgrad Serbia 11000
    48 Institute of Cardiovascular Diseases "Dedinje" Belgrad Serbia 11040
    49 General Hospital "Sveti Luka" Smederevo Serbia 11300
    50 Institute for Cardiovascular Diseases of Vojvodina Sremska Kamenica Serbia 21204
    51 University Medical Centre Ljubljana (07-03) Ljubljana Slovenia 1000
    52 General Hospital Murska Sobota Division of Cardiology (07-01) Murska Sobota Slovenia 9000
    53 Hospital Topolšica (07-03) Topolšica Slovenia SI-3326
    54 Hospital del Mar (04-01) Barcelona Spain 08003
    55 Hospital Universitario Clinico San Carlos Madrid (04-04) Madrid Spain 28040
    56 Hospital Universitarion Virgen de la Victoria (04-03) Málaga Spain 29010
    57 Hospital Clinico Universitario Valencia (04-02) Valencia Spain 46010
    58 Hospital la Fe de Valencia (04-05) Valencia Spain 46026

    Sponsors and Collaborators

    • Universitätsklinikum Hamburg-Eppendorf
    • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
    • Charite University, Berlin, Germany

    Investigators

    • Principal Investigator: Mahir Karaks, MD, Universitätsklinikum Hamburg-Eppendorf

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitätsklinikum Hamburg-Eppendorf
    ClinicalTrials.gov Identifier:
    NCT03036462
    Other Study ID Numbers:
    • FAIR-HF2
    • FAIR-HF2-DZHK5
    First Posted:
    Jan 30, 2017
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Universitätsklinikum Hamburg-Eppendorf
    intravenous iron
    systolic heart failure
    iron deficiency
    morbidity
    mortality
    Additional relevant MeSH terms:
    Heart Failure
    Heart Failure, Systolic
    Anemia, Iron-Deficiency
    Systolic Murmurs

    Study Results

    No Results Posted as of Oct 12, 2021