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

NCT07708025 | Completed Phase 3

• 1 other identifier: Oral iron & SGLT2i HF
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Anemia

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin Levels

  Change from baseline in hemoglobin levels measured by laboratory blood tests

  Baseline, 3-4 months, and 5-6 months

Secondary Outcomes (5)

• Change in Hematocrit

  Baseline, 3-4 months, and 5-6 months

• Change in Transferrin Saturation

  Baseline, 3-4 months, and 5-6 months

• Change in Serum Iron

  Baseline, 3-4 months, and 5-6 months

• Change in Ferritin

  Baseline, 3-4 months, and 5-6 months

• Change in Total Iron-Binding Capacity (TIBC)

  Baseline, 3-4 months, and 5-6 months

Study Arms (1)

Oral iron supplementation

EXPERIMENTAL

either hydroxide polymaltose \[Ferrum Haussman®\] or ferrous sulfate \[Ferro Gradumet®\]

Drug: Oral iron supplementation

Interventions

Oral iron supplementation DRUG

Oral iron supplementation administered at the treating physician's discretion

Also known as: Hydroxide polymaltose, Ferrous sulfate

Oral iron supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Previous diagnosis of heart failure, irrespective of ejection fraction;
• \) Iron deficiency anemia defined as hemoglobin \<13 g/dL in men or \<12 g/dL in women, with transferrin saturation (TSAT) \<20%;
• \) Ongoing treatment with an SGLT2 inhibitor (SGLT2i) for more than 3 months at the time of enrollment.

You may not qualify if:

• \) Concomitant use of intravenous iron, erythropoiesis-stimulating agents (ESAs), red blood cell transfusions, or other blood products within 3 months before enrollment;
• \) Severe anemia, defined as hemoglobin \<7 g/dL or clinical indication for transfusion;
• \) Relevant intercurrent illnesses associated with inflammatory response (e.g., infection, acute kidney injury, or acute decompensated heart failure) within 3 months before enrollment;
• \) Confirmed or suspected active bleeding;
• \) End-stage renal disease or receiving renal replacement therapy;
• \) History of any type of active cancer;
• \) History of solid or non-solid organ transplantation.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Unidade Local de Saúde São João

Porto, 4200-319, Portugal

Location

MeSH Terms

Conditions

Heart Failure; Anemia

Interventions

teferrol; ferrous sulfate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• João P. Ferreira, PhD. MD.

  Universidade do Porto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: July 16, 2026
• Study Start: September 20, 2025
• Primary Completion: February 26, 2026
• Study Completion: March 15, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-02

Locations

PT (1)