Study to investigate the improvement on morbitity and mortality and frequence of disease by intravenous iron therapy in patients with disturbance of heart function and iron deficiency

Intravenous iron in patients with systolic heart failure and iron deficiency to improve morbidity & mortality. Ferric carboxymaltose Assessment of morbidity and mortality in patients with IRon deficiency and chronic Heart Failure – FAIR–HF2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000068-40-DE

Enrollment

1200

Registered

2016-09-12

Start date

2017-01-27

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systolic heart failure associated with iron deficiency MedDRA version: 20.0 Level: LLT Classification code 10074631 Term: Systolic heart failure System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Ferinject Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Concentration unit: mg/ml milligram(s)/millilitre Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with chronic HFrEF (CHF) of at least 3 months duration and a history of documented LVEF 100 pg/mL or NT-proBNP > 300 pg/mL or MR-proANP > 120 pmol/L (NYHA 2-4) 5. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 165 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 335

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to the active substance, to FCM or any of its excipients 2. Known serious hypersensitivity to other parenteral iron products 3. Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia 4. Evidence of iron overload or disturbances in the utilisation of iron 5. History of severe asthma with known FEV1 80% of the patients with a TSAT 75% of the patients with ischemic cardiomyopathy

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the FAIR-HF2 trial is to show that treatment of patients with systolic heart failure and iron deficiency with i.v. iron (Ferric Carboxymaltose, FCM) versus placebo (i.v. NaCl) can extend the time-to-first-event of heart failure hospitalisations and cardiovascular (CV) death (in the full population and in the population of patients with TSAT<20%) and reduce the rate of recurrent events of heart failure hospitalisations.;Secondary Objective: Secondary objectives include the demonstration that in these patients treatment with FCM versus placebo can improve patient-related outcomes (i.e., NYHA class, EQ5-D, 6MWT and PGA). An additional aim is to show the cost-effectiveness of the intervention.;Primary end point(s): • Time-to-first event of CV death or HF hospitalisation • Rate of total (first and recurrent) events of hospitalisations for heart failure • Time-to-first event of CV death or HF hospitalisation in patients with TSAT <20%.;Timepoint(s) of evaluation of this end point: During follow-up	—

Measure

Time frame

Main Objective: The primary objective of the FAIR-HF2 trial is to show that treatment of patients with systolic heart failure and iron deficiency with i.v. iron (Ferric Carboxymaltose, FCM) versus placebo (i.v. NaCl) can extend the time-to-first-event of heart failure hospitalisations and cardiovascular (CV) death (in the full population and in the population of patients with TSAT<20%) and reduce the rate of recurrent events of heart failure hospitalisations.;Secondary Objective: Secondary objectives include the demonstration that in these patients treatment with FCM versus placebo can improve patient-related outcomes (i.e., NYHA class, EQ5-D, 6MWT and PGA). An additional aim is to show the cost-effectiveness of the intervention.;Primary end point(s): • Time-to-first event of CV death or HF hospitalisation • Rate of total (first and recurrent) events of hospitalisations for heart failure • Time-to-first event of CV death or HF hospitalisation in patients with TSAT <20%.;Timepoint(s) of evaluation of this end point: During follow-up

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Endpoints: • Changes in 6-minute walk-test, NYHA functional class, EQ-5D, and PGA of wellbeing during follow-up (from baseline to 12 months of follow-up) • Exploratory: Changes in renal, cardiovascular, inflammatory and metabolic parameters during follow-up (from baseline to various time-points of follow-up) Further analyses: For the primary clinical efficacy endpoint, as well as other important clinical endpoints – especially recurrent heart failure hospitalisations, recurrent CV hospitalisations; CV death, all-cause-death, and combinations thereof - a meta-analysis with all other relevant controlled clinical trials testing ferric carboxymaltose and/ or other iv iron formulations (e.g. FAIR-HF, AFFIRM-AHF, CONFIRM-HF, IRON-MAN, HEART-FID) will be performed: (i) only trials using FCM (ii) all trials using any iv iron formulations Key Safety Endpoints: • CV mortality during 36 months of follow-up • All-cause mortality during 36 months of follow-up;Timepoint(s) of evaluation of this end point: We aim for a minimum average follow-up of >2 years. We aim for a minimum follow-up of 6 months for all patients, but not less than 3 months.	—

Measure

Time frame

Secondary end point(s): Secondary Endpoints: • Changes in 6-minute walk-test, NYHA functional class, EQ-5D, and PGA of wellbeing during follow-up (from baseline to 12 months of follow-up) • Exploratory: Changes in renal, cardiovascular, inflammatory and metabolic parameters during follow-up (from baseline to various time-points of follow-up) Further analyses: For the primary clinical efficacy endpoint, as well as other important clinical endpoints – especially recurrent heart failure hospitalisations, recurrent CV hospitalisations; CV death, all-cause-death, and combinations thereof - a meta-analysis with all other relevant controlled clinical trials testing ferric carboxymaltose and/ or other iv iron formulations (e.g. FAIR-HF, AFFIRM-AHF, CONFIRM-HF, IRON-MAN, HEART-FID) will be performed: (i) only trials using FCM (ii) all trials using any iv iron formulations Key Safety Endpoints: • CV mortality during 36 months of follow-up • All-cause mortality during 36 months of follow-up;Timepoint(s) of evaluation of this end point: We aim for a minimum average follow-up of >2 years. We aim for a minimum follow-up of 6 months for all patients, but not less than 3 months.

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Countries

Germany, Hungary, Italy, Poland, Portugal, Serbia, Slovenia, Spain

Contacts

Public ContactMahir Karakas

University Medical Center Hamburg-Eppendorf

m.karakas@uke.de004940741057975

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026