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

This clinical trial is looking at how intravenous (IV) iron treatment, alone or with an SGLT2 inhibitor (a type of medication), affects heart function in patients with heart failure and iron deficiency. Heart failure means the heart isn’t pumping blood as well as it should, and iron deficiency can make symptoms worse. The researchers want to see if adding IV iron improves the heart's performance and the amount of iron in the heart muscle itself.

To be eligible for this study, participants need to be at least 18 years old, have a specific level of heart function (an ejection fraction of 40% or less), and have low iron levels in their blood. They should not have any serious kidney problems or certain heart diseases. If you join the trial, you’ll be monitored closely and may receive either IV iron or the combination of IV iron and the SGLT2 inhibitor. This study is currently not recruiting, so it’s in the planning phase. Overall, this research aims to better understand how these treatments can help improve the quality of life for people with heart failure and iron deficiency.

Gender

ALL

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.