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

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ClinicalTrials.gov Identifier: NCT03036462
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : May 8, 2020
Sponsor:
Collaborators:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Study Description
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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
Systolic Heart Failure Iron Deficiency Drug: Iron Drug: Saline 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 7, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arms and Interventions
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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 Name: salin


Outcome Measures
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Primary Outcome Measures :
  1. Combined rate of recurrent hospitalisations for heart failure (HF) and of cardiovascular death (number of events) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: at least after 12 month of follow-up ]
    All-cause mortality during follow-up

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

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

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

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

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

  12. Changes in renal parameters (laboratory parameters) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: at least after 12 month of follow-up ]
    Changes in metabolic parameters from baseline to end of follow-up


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036462


Contacts
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Contact: Mahir Karakas, MD 0049 407410 ext 57975 m.karakas@uke.de
Contact: Stefan Anker, MD s.anker@cachexia.de

Locations
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Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Mahir Karaks, MD Universitätsklinikum Hamburg-Eppendorf
More Information
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03036462    
Other Study ID Numbers: FAIR-HF2
FAIR-HF2-DZHK5 ( Other Grant/Funding Number: Deutsches Zentrum für Herzkreislaufforschung )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Heart Failure
Heart Failure, Systolic
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
 Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases