Iron infusion and dapagliflozin in heart failure with iron deficiency
Tests iron infusion with or without dapagliflozin in adults with heart failure and low iron.
Plain-language title generated from the registry record
Registry title: IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency
Key facts
- Where
- Porto Alegre, BrazilSee the site
- Phase
- Phase 3
Where in Brazil
- Hospital de Clinicas de Porto AlegrePorto Alegre, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital de Clinicas de Porto Alegre
- Trial code
- NCT06434025
- Record updated
- 3 June 2024
- Original description
Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, the mechanisms underlying these beneficial effects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content.Read full original descriptionShow less
Effect of Combination of Intravenous Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Patients With Heart Failure and Iron Deficiency.
Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, the mechanisms underlying these beneficial effects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content.
This study aims to measure cardiac magnetic resonance changes in myocardial iron content and in left ventricular function after administration of intravenous iron with and without the concomitant use of SGLT2 inhibitor in patients with HFrEF and iron deficiency.
Inclusion: Age 18 years or over; Ejection fraction (EF) ≤40%, estimated by color Doppler echocardiography or CMR or radionuclide ventriculography; Serum ferritin <100 µg/L or serum ferritin between 100 and 299 µg/L and transferrin saturation <20%; Serum hemoglobin between 9.5 and 13.5 mg/dL; Patients must be SGLT2 naive; Informed consent form (ICF) signed.
Exclusion: Blood transfusion within 30 days prior to CMR examination; Kidney disease requiring dialysis or chronic kidney disease not requiring dialysis with an estimated glomerular filtration rate <30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; Severe primary valve disease; Acute coronary syndrome requiring cardiac surgery or coronary artery bypass surgery in the past 3 months; Patients with a pacemaker, cardiac resynchronization therapy, or implantable defibrillator; Patients already being treated for some type of non-iron deficiency anemia; Diagnosis of hemochromatosis.