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

Phase 1

Conditions: Systolic heart failure associated with iron deficiency
MedDRA version: 20.0Level: LLTClassification code 10074631Term: Systolic heart failureSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2016-000068-40-IT

Lead Sponsor: IVERSITäTKLINIKUM HAMBURG-EPPENDORF

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1200

Inclusion Criteria

1.Patients with chronic HF (CHF) present for at least 12 months
2.Confirmed presence of ID (ferritin < 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT < 20 %)
3.Serum haemoglobin of 9.5 to 14.0 g/dL
4.At time of screening considered re-stabilized and planned for discharge within next 24 h, or stable ambulatory with a HF hospitalisation in the past 6 months, or stable ambulatory with BNP > 100 pg/mL or NT-proBNP > 300 pg/mL or MR-proANP > 120 pmol/L
5.LVEF = 45 % (documented within the last 12 months prior to screening), NYHA class II or III
6.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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

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, eczema or other atopic allergy
6.History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
7.Acute or chronic infection
8.Presence of a deficiency for vitamin B12 and/or serum folate (if present, this needs to be corrected first)
9.Use of renal replacement therapy
10.Known allergy to FCM or its excipients
11.Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 6 weeks prior to randomization.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 reduce the rate of the combined endpoint of recurrent heart failure hospitalisations and cardiovascular death during at least 12 months follow-up.;Secondary Objective: Secondary objectives include the demonstration that in these patients treatment with FCM versus placebo can reduce the rate of recurrent cardiovascular hospitalisations, the rate of recurrent hospitalisations of any kind, and of all-cause mortality. An additional aim is to show the cost-effectiveness of the intervention.;Primary end point(s): Combined rate of recurrent hospitalisations for heart failure and of CV death during follow-up;Timepoint(s) of evaluation of this end point: At least after 12 month of follow up<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Combined rate of recurrent CV hospitalisations and of CV death during follow-up<br>•Combined rate of recurrent hospitalisations for any reason and of CV death<br>•Rate of recurrent CV hospitalisations<br>•Rate of recurrent HF hospitalisations<br>•Rate of recurrent hospitalisations of any kind<br>•All-cause mortality<br>•CV mortality<br>•Changes in NYHA functional class, 6-minute walk-test, EQ-5D, and PGA of wellbeing during follow-up (from baseline to vari-ous time-points of follow-up)<br>•Changes in renal, cardiovascular, inflammatory and metabolic parameters from baseline to end of follow-up;Timepoint(s) of evaluation of this end point: At least after 12 month of follow up

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