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People with heart failure often have anemia caused by low iron levels. Ongoing inflammation in heart failure can impair iron absorption, making oral iron therapy less effective.
Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are medications used to treat heart failure. In addition to their cardiovascular benefits, these drugs may improve iron metabolism and support red blood cell production.
This study evaluates whether patients with heart failure and iron deficiency anemia who are receiving SGLT2i therapy respond to treatment with oral iron. Participants receive oral iron for three to four months, followed by a short period without treatment. Blood tests are used to assess changes in hemoglobin levels.
The objective of this study is to determine whether treatment with SGLT2i enhances the response to oral iron in patients with heart failure and iron deficiency anemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral iron supplementation | Experimental | either hydroxide polymaltose [Ferrum Haussman®] or ferrous sulfate [Ferro Gradumet®] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral iron supplementation | Drug | Oral iron supplementation administered at the treating physician's discretion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Levels | Change from baseline in hemoglobin levels measured by laboratory blood tests | Baseline, 3-4 months, and 5-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hematocrit | Change from baseline in hematocrit measured by laboratory blood tests | Baseline, 3-4 months, and 5-6 months |
| Change in Transferrin Saturation | Change from baseline in transferrin saturation measured by laboratory blood tests. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| João P. Ferreira, PhD. MD. | Universidade do Porto | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade Local de Saúde São João | Porto | 4200-319 | Portugal |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C013276 | teferrol |
| C020748 | ferrous sulfate |
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| Baseline, 3-4 months, and 5-6 months |
| Change in Serum Iron | Change from baseline in serum iron measured by laboratory blood tests. | Baseline, 3-4 months, and 5-6 months |
| Change in Ferritin | Change from baseline in ferritin measured by laboratory blood tests. | Baseline, 3-4 months, and 5-6 months |
| Change in Total Iron-Binding Capacity (TIBC) | Change from baseline in TIBC measured by laboratory blood tests. | Baseline, 3-4 months, and 5-6 months |