- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07708025
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
-
Porto, Portugal, 4200-319
- Unidade Local de Saúde São João
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Oral iron supplementation
either hydroxide polymaltose [Ferrum Haussman®] or ferrous sulfate [Ferro Gradumet®]
|
Oral iron supplementation administered at the treating physician's discretion
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Hemoglobin Levels
Tidsramme: Baseline, 3-4 months, and 5-6 months
|
Change from baseline in hemoglobin levels measured by laboratory blood tests
|
Baseline, 3-4 months, and 5-6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Hematocrit
Tidsramme: Baseline, 3-4 months, and 5-6 months
|
Change from baseline in hematocrit measured by laboratory blood tests
|
Baseline, 3-4 months, and 5-6 months
|
|
Change in Transferrin Saturation
Tidsramme: Baseline, 3-4 months, and 5-6 months
|
Change from baseline in transferrin saturation measured by laboratory blood tests.
|
Baseline, 3-4 months, and 5-6 months
|
|
Change in Serum Iron
Tidsramme: Baseline, 3-4 months, and 5-6 months
|
Change from baseline in serum iron measured by laboratory blood tests.
|
Baseline, 3-4 months, and 5-6 months
|
|
Change in Ferritin
Tidsramme: Baseline, 3-4 months, and 5-6 months
|
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)
Tidsramme: Baseline, 3-4 months, and 5-6 months
|
Change from baseline in TIBC measured by laboratory blood tests.
|
Baseline, 3-4 months, and 5-6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: João P. Ferreira, PhD. MD., Universidade do Porto
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Oral iron & SGLT2i HF
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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