Intravenous Iron in paTients With Heart failURe and Reduced Ejection fracTion (HFREF) pLus Iron dEficiency
NCT ID: NCT03079518
Last Updated: 2017-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2017-03-10
2017-10-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with HFREF & CKD
treated with intravenous single-shot 1000mg Ferric Carboxymaltose infusion; additional intervention: blood withdrawal
Ferric Carboxymaltose
single shot infusion
blood withdrawal
for determination of serum and urinary biomarkers of chronic kidney disease metabolism and other parameters
Patients with HFREF
treated with intravenous single-shot 1000mg Ferric Carboxymaltose infusion; additional intervention: blood withdrawal
Ferric Carboxymaltose
single shot infusion
blood withdrawal
for determination of serum and urinary biomarkers of chronic kidney disease metabolism and other parameters
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ferric Carboxymaltose
single shot infusion
blood withdrawal
for determination of serum and urinary biomarkers of chronic kidney disease metabolism and other parameters
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RWTH Aachen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16-047
Identifier Type: -
Identifier Source: org_study_id