Heart FailurePhase 3NCT07708025
Oral Iron for the Management of Iron Deficiency Anemia in SGLT2i-Treated Heart Failure Patients
A Phase 3 study testing Oral iron supplementation in people with Heart Failure and Anemia, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Anemia
- What is being tested?
- Oral iron supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Sep 2025to 15 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Oral iron supplementation
- Medical subject headings
- Heart Failure, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral iron supplementationDrug
Also called Hydroxide polymaltose, Ferrous sulfate
Oral iron supplementation administered at the treating physician's discretion
| Study group | Role | What they receive |
|---|---|---|
| Oral iron supplementation | Experimental | either hydroxide polymaltose [Ferrum Haussman®] or ferrous sulfate [Ferro Gradumet®] Receives: Drug: Oral iron supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin Levels
Change from baseline in hemoglobin levels measured by laboratory blood tests
Measured: Baseline, 3-4 months, and 5-6 months
Secondary outcomes (5)
Change in Hematocrit
Change from baseline in hematocrit measured by laboratory blood tests
Measured: Baseline, 3-4 months, and 5-6 months
Change in Transferrin Saturation
Change from baseline in transferrin saturation measured by laboratory blood tests.
Measured: Baseline, 3-4 months, and 5-6 months
Change in Serum Iron
Change from baseline in serum iron measured by laboratory blood tests.
Measured: Baseline, 3-4 months, and 5-6 months
Change in Ferritin
Change from baseline in ferritin measured by laboratory blood tests.
Measured: 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.
Measured: Baseline, 3-4 months, and 5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start20 Sep 2025
- Primary completion26 Feb 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João P. Ferreira, PhD. MD., Study director, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708025
- Sponsor's protocol ID
- Oral iron & SGLT2i HF
- Status last verified
- Feb 2026
- First submitted
- 13 Apr 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Iron for the Management of Iron Deficiency Anemia in SGLT2i-Treated Heart Failure Patients: A Prospective Analysis
- ClinicalTrials.gov ID
- NCT07708025
- Acronym / sponsor ID
- Oral iron & SGLT2i HF
- Conditions
- Heart Failure, Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral iron supplementation | Experimental | Drug: Oral iron supplementationeither hydroxide polymaltose [Ferrum Haussman®] or ferrous sulfate [Ferro Gradumet®] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral iron supplementationAlso: Hydroxide polymaltose, Ferrous sulfateOral iron supplementation administered at the treating physician's discretion | Drug | Oral iron supplementation |
Primary outcome
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
5 secondary outcomes
Change in Hematocrit
Time frame: Baseline, 3-4 months, and 5-6 months
Change in Transferrin Saturation
Time frame: Baseline, 3-4 months, and 5-6 months
Change in Serum Iron
Time frame: Baseline, 3-4 months, and 5-6 months
Change in Ferritin
Time frame: Baseline, 3-4 months, and 5-6 months
Change in Total Iron-Binding Capacity (TIBC)
Time frame: Baseline, 3-4 months, and 5-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João P. Ferreira, PhD. MD. study director
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral iron supplementation in people with Heart Failure and Anemia, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin Levels (time frame: Baseline, 3-4 months, and 5-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.