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

  • STATUS
    Recruiting
  • End date
    May 18, 2024
  • participants needed
    1200
  • sponsor
    Universitätsklinikum Hamburg-Eppendorf
Updated on 24 February 2022
iron deficiency anemia
iron
heart failure
chronic heart failure
systolic heart failure
malnutrition
haem

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.

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 g/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.

Details
Condition Systolic Heart Failure, Iron Deficiency
Treatment Saline, iron
Clinical Study IdentifierNCT03036462
SponsorUniversitätsklinikum Hamburg-Eppendorf
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

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
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