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| Name | Class |
|---|---|
| Syneos Health | OTHER |
| ClinStar, LLC | INDUSTRY |
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This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferinject ® (Ferric carboxymaltose) | Drug | Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit. After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase). |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Key secondary objectives (efficacy): Exercise tolerance (6-minute walk test distance). Further secondary objectives(efficacy): Health related quality of life, resource use and costs associated with the treatment, safety and tolerability | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip A Poole-Wilson, MD FRCP | National Heart and Lung Institute. Faculty of Medicine. Imperial College London. Dovehouse Street, London SW3 6LY, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Sites | Buenos Aires | Argentina | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19920054 | Derived | Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17. | |
| 19875408 |
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|
| Normal saline (0.9%) | Drug | During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly. |
|
| Bad Nauheim |
| Germany |
| Research Site | Berlin | Germany |
| Research Site | Göttingen | Germany |
| Research Site | Hanover | Germany |
| Research Sites | Heidelberg | Germany |
| Research Site | Herford | Germany |
| Research Site | Herne | Germany |
| Research Site | Kiel | Germany |
| Research Site | München | Germany |
| Research Site | Athens | Greece |
| Research Site | Heraklion | Greece |
| Research Site | Ascoli Piceno | Italy |
| Research Site | Pavia | Italy |
| Research Site | Rome | Italy |
| Research Site | Vicenza | Italy |
| Research Site | Stavanger | Norway |
| Research Site | Bialystok | Poland |
| Research Site | Krakow | Poland |
| Research Site | Opole | Poland |
| Research Site | Piotrkow Trybunalski | Poland |
| Research Site | Siedlce | Poland |
| Research Site | Torun | Poland |
| Research Sites | Warsaw | Poland |
| Research Site | Wałbrzych | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Włocławek | Poland |
| Research Site | Zabrze | Poland |
| Research Site | Brasov | Romania |
| Research Sites | Bucharest | Romania |
| Reserach Site | Craiova | Romania |
| Research Sites | Târgu Mureş | Romania |
| Reserach Sites | Moscow | Russia |
| Resarch Sites | Saint Petersburg | Russia |
| Research Sites | Veliky Novgorod | Russia |
| Research Site | Alicante | Spain |
| Research Sites | Barcelona | Spain |
| Research Site | Bilbao | Spain |
| Research Site | Madrid | Spain |
| Research Site | Valencia | Spain |
| Research Site | Dnipropetrovsk | Ukraine |
| Research Site | Donetsk | Ukraine |
| Research Site | Kharkiv | Ukraine |
| Research Sites | Kiev | Ukraine |
| Research Site | Lviv | Ukraine |
| Research Site | Mykolayiv | Ukraine |
| Research Site | Odesa | Ukraine |
| Research Site | Zaporizhzhya | Ukraine |
| Derived |
| Anker SD, Colet JC, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Mori C, von Eisenhart Rothe B, Pocock S, Poole-Wilson PA, Ponikowski P; FAIR-HF committees and investigators. Rationale and design of Ferinject assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia. Eur J Heart Fail. 2009 Nov;11(11):1084-91. doi: 10.1093/eurjhf/hfp140. |
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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