Intravenous Iron in paTients With Heart failURe and Reduced Ejection fracTion (HFREF) pLus Iron dEficiency

• Status: Completed
• Trial end date: 2017-10-25
• Target enrollment: 0
• Participant gender: All

Summary

Effects of ferric carboxymaltose single HD (1000 mg) infusion upon FGF23 in patients with isolated HFREF compared to patients with HFREF+CKD (all pts with iron deficiency). This study aims at identification of the optimal target population for a follow-up ("main") study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWTH Aachen University
• Treatments: Ferric Compounds

Criteria

Inclusion Criteria:

• Written informed consent.

• Age > 18 yrs

• Symptomatic HFREF (LV ejection fraction < 45%) with optimal medical therapy (OMT) for at least 2 months

• Iron deficiency as indicated by by ferritin <100 ng/mL or ferritin 100-299 ng/ml when transferrin saturation (TSAT) <20% and Hb value < 13mg/dl (women) and <14 mg/dl (men)

• Group A: Stable CKD for at least 2 months, defined by estimated glomerular filtration rate (eGFR) (CKD-EPI formula) as 15-60 ml/min/1,73 m3 (CKD III, IV, V-non D)

• Group B: patients with stable eGFR > 60 ml/min/1,73 m3

Exclusion Criteria:

• Known hypersensitivity to ferric carboxymaltose or any constituents of the formulation,

• Plasma Phosphate < 2.5 mg/dL at screening,

• Renal replacement therapy/transplantation,

• Pregnancy or lactation

• iron substitution therapy or erythropoetin (epo) therapy within 6 weeks before

• participation in another clinical trial with an experimental drug

• expectation of missing compliance

• alcohol or drug abuse

• The subject is mentally or legally incapacitated

• patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative