About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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 already being treated for some type of non-iron deficiency anemia;
Trial design
Treatments tested in this trial
- Iron Carboxymaltose
- Dapagliflozin 10mg Tab
- Placebo of Iron Carboxymaltose
- Placebo of Dapagliflozin
Treatment groups
Sponsors and collaborators
Hospital de Clinicas de Porto Alegre
Lead sponsor
Vifor Pharma
Collaborator