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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

Tracking Information
First Submitted Date  ICMJE September 15, 2016
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date May 8, 2020
Actual Study Start Date  ICMJE February 7, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
  • All-cause mortality (number of events) [ Time Frame: at least after 12 month of follow-up ]
    All-cause mortality during follow-up
  • cardiovascular mortality (number of events) [ Time Frame: at least after 12 month of follow-up ]
    cardiovascular mortality during follow-up
  • 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
  • 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
  • Changes in EQ-5D (questionnaire) [ Time Frame: at least after 12 month of follow-up ]
    Changes EQ-5D during follow-up
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality
Official Title  ICMJE Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality - FAIR-HF2
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Systolic Heart Failure
  • Iron Deficiency
Intervention  ICMJE
  • Drug: Iron
    i.v. iron administration
  • Drug: Saline
    i.v. NaCl administration
    Other Name: salin
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Iron
  • 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.
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mahir Karakas, MD 0049 407410 ext 57975 m.karakas@uke.de
Contact: Stefan Anker, MD s.anker@cachexia.de
Listed Location Countries  ICMJE Germany,   Hungary,   Italy,   Poland,   Portugal,   Serbia,   Slovenia,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03036462
Other Study ID Numbers  ICMJE FAIR-HF2
FAIR-HF2-DZHK5 ( Other Grant/Funding Number: Deutsches Zentrum für Herzkreislaufforschung )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE
  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
  • Charite University, Berlin, Germany
Investigators  ICMJE
Principal Investigator: Mahir Karaks, MD Universitätsklinikum Hamburg-Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP