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Completed

NCT Number: NCT07708025

Oral Iron for the Management of Iron Deficiency Anemia in SGLT2i-Treated Heart Failure Patients

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Unidade Local de Saúde São João

Porto, 4200-319, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral iron supplementation

Drug

Oral iron supplementation administered at the treating physician's discretion

Other names: Hydroxide polymaltose, Ferrous sulfate

Primary outcomes

  1. Change in Hemoglobin Levels

    Time frame: Baseline, 3-4 months, and 5-6 months

    Change from baseline in hemoglobin levels measured by laboratory blood tests

Secondary outcomes

  1. Change in Hematocrit

    Time frame: Baseline, 3-4 months, and 5-6 months

    Change from baseline in hematocrit measured by laboratory blood tests

  2. Change in Transferrin Saturation

    Time frame: Baseline, 3-4 months, and 5-6 months

    Change from baseline in transferrin saturation measured by laboratory blood tests.

  3. Change in Serum Iron

    Time frame: Baseline, 3-4 months, and 5-6 months

    Change from baseline in serum iron measured by laboratory blood tests.

  4. Change in Ferritin

    Time frame: Baseline, 3-4 months, and 5-6 months

    Change from baseline in ferritin measured by laboratory blood tests.

  5. Change in Total Iron-Binding Capacity (TIBC)

    Time frame: Baseline, 3-4 months, and 5-6 months

    Change from baseline in TIBC measured by laboratory blood tests.

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study title

Oral Iron for the Management of Iron Deficiency Anemia in SGLT2i-Treated Heart Failure Patients: A Prospective Analysis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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