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

NCT03079518 | Completed Phase 2

• 1 other identifier: 16-047
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure, Systolic; Iron Deficiency

Keywords

iron deficiency; HFREF; FGF23; ferric carboxymaltose

Outcome Measures

Primary Outcomes (2)

• changes in blood intact FGF23 after infusion of 1000 mg ferric carboxymaltose

  intact FGF23 concentration in kRU/l

  4 weeks

• changes in blood c-term FGF23 after infusion of 1000 mg ferric carboxymaltose

  c-terminal FGF23 concentration in kRU/l

  4 weeks

Secondary Outcomes (4)

• changes of serum biomarkers of chronic kidney disease metabolism

  4 weeks

• changes of urinary marker of tubular damage

  4 weeks

• phosphate level

  4 weeks

• changes of Inflammatory mediators

  4 weeks

Study Arms (2)

Patients with HFREF & CKD

ACTIVE COMPARATOR

treated with intravenous single-shot 1000mg Ferric Carboxymaltose infusion; additional intervention: blood withdrawal

Drug: Ferric Carboxymaltose; Other: blood withdrawal

Patients with HFREF

ACTIVE COMPARATOR

treated with intravenous single-shot 1000mg Ferric Carboxymaltose infusion; additional intervention: blood withdrawal

Drug: Ferric Carboxymaltose; Other: blood withdrawal

Interventions

Ferric Carboxymaltose DRUG

single shot infusion

Also known as: Ferinject

Patients with HFREF; Patients with HFREF & CKD

blood withdrawal OTHER

for determination of serum and urinary biomarkers of chronic kidney disease metabolism and other parameters

Patients with HFREF; Patients with HFREF & CKD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (1)

• Stohr R, Sandstede L, Heine GH, Marx N, Brandenburg V. High-Dose Ferric Carboxymaltose in Patients With HFrEF Induces Significant Hypophosphatemia. J Am Coll Cardiol. 2018 May 15;71(19):2270-2271. doi: 10.1016/j.jacc.2018.03.448. No abstract available.

  PMID: 29747838 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic; Iron Deficiencies

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 14, 2017
• Study Start: March 10, 2017
• Primary Completion: October 25, 2017
• Study Completion: October 25, 2017
• Last Updated: December 6, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)