IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency

Launched by HOSPITAL DE CLINICAS DE PORTO ALEGRE · May 23, 2024

Keywords

ClinConnect Summary

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 after administration of intravenous iron and to assess changes in left ventricular function in patients with HFrEF and iron deficiency.

Method...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or over;
• • 2. Ejection fraction (EF) ≤40%, estimated by color Doppler echocardiography or CMR or radionuclide ventriculography;
• • 3. Serum ferritin \<100 µg/L or serum ferritin between 100 and 299 µg/L and transferrin saturation \<20%;
• • 4. Serum hemoglobin between 9.5 and 13.5 mg/dL;
• • 5. Patients must be SGLT2 naive;
• • 6. Informed consent form (ICF) signed.
• Exclusion Criteria:
• • 1. 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;
• • 2. Severe primary valve disease;
• • 3. Acute coronary syndrome requiring cardiac surgery or coronary artery bypass surgery in the past 3 months;
• • 4. Patients already being treated for some type of non-iron deficiency anemia;
• • 5. Blood transfusion within 30 days prior to CMR examination;
• • 6. Patients with a pacemaker, cardiac resynchronization therapy, or implantable defibrillator;
• • 7. Diagnosis of hemochromatosis.

Trial Officials