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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000603-40 | EudraCT Number |
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The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves exercise capacity, physical functioning and quality of life in patients with iron deficiency and chronic heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferinject (ferric carboxymaltose) | Experimental |
| |
| Standard of Care | Other | Standard of care. IV iron is not permitted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferinject (ferric carboxymaltose) | Drug | Subjects will receive ferric carboxymaltose intravenously on Day 0, Week 6, and Week 12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak VO2 (mL/kg/min) from baseline to Week 24 | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk van Veldhuisen, MD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9700 RB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28701470 | Derived | van Veldhuisen DJ, Ponikowski P, van der Meer P, Metra M, Bohm M, Doletsky A, Voors AA, Macdougall IC, Anker SD, Roubert B, Zakin L, Cohen-Solal A; EFFECT-HF Investigators. Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Chronic Heart Failure and Iron Deficiency. Circulation. 2017 Oct 10;136(15):1374-1383. doi: 10.1161/CIRCULATIONAHA.117.027497. Epub 2017 Jul 12. |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Subjects randomised to Standard of Care may receive oral iron at Investigator's discretion however patients will not be permitted to receive IV iron |
|