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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with HFREF & CKD | Active Comparator | treated with intravenous single-shot 1000mg Ferric Carboxymaltose infusion; additional intervention: blood withdrawal |
|
| Patients with HFREF | Active Comparator | treated with intravenous single-shot 1000mg Ferric Carboxymaltose infusion; additional intervention: blood withdrawal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Carboxymaltose | Drug | single shot infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| changes of serum biomarkers of chronic kidney disease metabolism | PTH, Vitamin D, ALP, s-klotho, PINP, proBNP | 4 weeks |
| changes of urinary marker of tubular damage | NGAL, KIM-1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29747838 | Derived | 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. |
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IPD will not be shared due to publication afterwards
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| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D019189 | Iron Metabolism Disorders |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
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| blood withdrawal | Other | for determination of serum and urinary biomarkers of chronic kidney disease metabolism and other parameters |
|
| 4 weeks |
| phosphate level | < 1,25 mg/dL | 4 weeks |
| changes of Inflammatory mediators | IL1, IL6, TNF-alpha, hsCRP | 4 weeks |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |