Anemia, Heart Failure
Conditions
Brief summary
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.
Interventions
Oral iron supplementation administered at the treating physician's discretion
Sponsors
Universidade do Porto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\) Previous diagnosis of heart failure, irrespective of ejection fraction; * 2\) Iron deficiency anemia defined as hemoglobin \<13 g/dL in men or \<12 g/dL in women, with transferrin saturation (TSAT) \<20%; * 3\) Ongoing treatment with an SGLT2 inhibitor (SGLT2i) for more than 3 months at the time of enrollment.
Exclusion criteria
* 1\) Concomitant use of intravenous iron, erythropoiesis-stimulating agents (ESAs), red blood cell transfusions, or other blood products within 3 months before enrollment; * 2\) Severe anemia, defined as hemoglobin \<7 g/dL or clinical indication for transfusion; * 3\) Relevant intercurrent illnesses associated with inflammatory response (e.g., infection, acute kidney injury, or acute decompensated heart failure) within 3 months before enrollment; * 4\) Confirmed or suspected active bleeding; * 5\) End-stage renal disease or receiving renal replacement therapy; * 6\) History of any type of active cancer; * 7\) History of solid or non-solid organ transplantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin Levels | Baseline, 3-4 months, and 5-6 months | Change from baseline in hemoglobin levels measured by laboratory blood tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hematocrit | Baseline, 3-4 months, and 5-6 months | Change from baseline in hematocrit measured by laboratory blood tests |
| Change in Transferrin Saturation | Baseline, 3-4 months, and 5-6 months | Change from baseline in transferrin saturation measured by laboratory blood tests. |
| Change in Serum Iron | Baseline, 3-4 months, and 5-6 months | Change from baseline in serum iron measured by laboratory blood tests. |
| Change in Ferritin | Baseline, 3-4 months, and 5-6 months | Change from baseline in ferritin measured by laboratory blood tests. |
| Change in Total Iron-Binding Capacity (TIBC) | Baseline, 3-4 months, and 5-6 months | Change from baseline in TIBC measured by laboratory blood tests. |
Countries
Portugal
Contacts
STUDY_DIRECTORJoão P. Ferreira, PhD. MD.
Universidade do Porto
Outcome results
None listed