Intravenous iron in patients with heart failure and reduced ejection fraction (HFREF) plus iron deficiency:Effects upon phosphate and FGF23 metabolism - Iron Turtle

Phase 1

• Conditions: Systolic heart failure (heart failure with reduced ejection fraction, HFREF) + iron deficiency with serum ferritin <100 µg/l or 100 – 299 µg/L when transferrin saturation (TSAT) is <20%; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-004147-37-DE
• Lead Sponsor: Center for Translational & Clinical Research Aachen (CTC-A)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-24
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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 TSAT <20% and Hb value < 13mg/dl (women) and <14 mg/dl (men)
- Group A: Stable CKD for at least 2 months, defined by 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

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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified