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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Anemia
• Intervention / Treatment: Drug: Oral iron supplementation

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 3

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Unidade Local de Saúde São João

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral iron supplementation; either hydroxide polymaltose [Ferrum Haussman®] or ferrous sulfate [Ferro Gradumet®]	Drug: Oral iron supplementation; Oral iron supplementation administered at the treating physician's discretion; Other Names: Ferrous sulfate; Hydroxide polymaltose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Investigators: Study Director: João P. Ferreira, PhD. MD., Universidade do Porto

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2025
• Primary Completion (Actual): February 26, 2026
• Study Completion (Actual): March 15, 2026

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Heart Failure; Anemia; ferrous sulfate; teferrol
• Other Study ID Numbers: Oral iron & SGLT2i HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No