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Trial record 92 of 383 for:    FERRIC CATION

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

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ClinicalTrials.gov Identifier: NCT03079518
Recruitment Status : Completed
First Posted : March 14, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease Intervention/treatment Phase
Heart Failure, Systolic Iron Deficiency Drug: Ferric Carboxymaltose Other: blood withdrawal Phase 2

Detailed Description:

Iron deficiency is highly prevalent in patients with HFREF and intravenous high-dose (HD) iron application has significantly improved clinically meaningful endpoints in such patients. The best evidence is existent for ferric carboxymaltose. Intravenous HD iron may influence phosphate metabolism via increases in levels of intact FGF23 and hence induce prolonged hypophosphatemia. Such increases in FGF23 may particularly occur depending on the type of iron carrier.

FGF23 is a significant risk factor for mortality and morbidity in patients with HFREF and other cardiac populations at risk and may directly cause left ventricular hypertrophy and dysfunction. Hence, the application of i.v. HD iron may have potentially beneficial effects on cardiac function but harmful effects via FGF23-induction and hypophosphatemia at the same time. However, FGF23 metabolism has not yet been evaluated in HFREF patients following i.v. HD iron.

FGF23 is elevated in patients with chronic kidney disease. Patients with HFREF + CKD = chronic cardio-renal syndrome are at particular risk regarding elevated morbidity and mortality. The effects of intravenous HD iron upon phosphate and FGF23 metabolism in patients with HFREF + CKD is unknown and effects in this setting may be different compared to effects in patients without pre-existing FGF23 stimulation.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Iron in paTients With Heart failURe and Reduced Ejection fracTion (HFREF) pLus Iron dEficiency: Effects Upon Phosphate and FGF23 Metabolism
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : October 25, 2017
Actual Study Completion Date : October 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arm Intervention/treatment
Active Comparator: Patients with HFREF & CKD
treated with intravenous single-shot 1000mg Ferric Carboxymaltose infusion; additional intervention: blood withdrawal
Drug: Ferric Carboxymaltose
single shot infusion
Other Name: Ferinject

Other: blood withdrawal
for determination of serum and urinary biomarkers of chronic kidney disease metabolism and other parameters

Active Comparator: Patients with HFREF
treated with intravenous single-shot 1000mg Ferric Carboxymaltose infusion; additional intervention: blood withdrawal
Drug: Ferric Carboxymaltose
single shot infusion
Other Name: Ferinject

Other: blood withdrawal
for determination of serum and urinary biomarkers of chronic kidney disease metabolism and other parameters




Primary Outcome Measures :
  1. changes in blood intact FGF23 after infusion of 1000 mg ferric carboxymaltose [ Time Frame: 4 weeks ]
    intact FGF23 concentration in kRU/l

  2. changes in blood c-term FGF23 after infusion of 1000 mg ferric carboxymaltose [ Time Frame: 4 weeks ]
    c-terminal FGF23 concentration in kRU/l


Secondary Outcome Measures :
  1. changes of serum biomarkers of chronic kidney disease metabolism [ Time Frame: 4 weeks ]
    PTH, Vitamin D, ALP, s-klotho, PINP, proBNP

  2. changes of urinary marker of tubular damage [ Time Frame: 4 weeks ]
    NGAL, KIM-1

  3. phosphate level [ Time Frame: 4 weeks ]
    < 1,25 mg/dL

  4. changes of Inflammatory mediators [ Time Frame: 4 weeks ]
    IL1, IL6, TNF-alpha, hsCRP



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079518


Locations
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Germany
Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03079518     History of Changes
Other Study ID Numbers: 16-047
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared due to publication afterwards

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by RWTH Aachen University:
iron deficiency
HFREF
FGF23
ferric carboxymaltose
Additional relevant MeSH terms:
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Ferric Compounds
Heart Failure
Heart Failure, Systolic
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Hematinics