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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
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The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferinject (ferric carboxymaltose) | Experimental |
| |
| Placebo (saline) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferinject (ferric carboxymaltose) | Drug | Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in six minute walk test from baseline to week 24 | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Ponikowski, MD | Cardiology Department - Centre for Heart Disease - Clinical Military Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Military Hospital | Wroclaw | 50-891 | Poland | |||
| State Educational Institution of Higer Professional Education |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25176939 | Derived | Ponikowski P, van Veldhuisen DJ, Comin-Colet J, Ertl G, Komajda M, Mareev V, McDonagh T, Parkhomenko A, Tavazzi L, Levesque V, Mori C, Roubert B, Filippatos G, Ruschitzka F, Anker SD; CONFIRM-HF Investigators. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiencydagger. Eur Heart J. 2015 Mar 14;36(11):657-68. doi: 10.1093/eurheartj/ehu385. Epub 2014 Aug 31. |
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| Placebo (saline) | Drug | Subjects will receive Placebo (saline) intravenously on Day 0 |
|
| Ryazan |
| 390039 |
| Russia |
| 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 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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