Heart Failure, Systolic Clinical Trial
— COMBINED-HFOfficial title:
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.
Status | Not yet recruiting |
Enrollment | 99 |
Est. completion date | November 24, 2026 |
Est. primary completion date | May 24, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 ?ltration 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 de?ciency 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre | Vifor Pharma |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | six minute walk test (6MWT) | distance walked in six minute walk test | 30 days | |
Other | NT-proBNP | NT-terminal pro-B-type natriuretic peptide (NT-proBNP) levels | 30 days | |
Other | MLHFQ | Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire | 30 days | |
Other | Hepcidin | Serum Hepcidin levels | 30 days | |
Other | Reticulocyte hemoglobin content | Reticulocyte hemoglobin content | 30 days | |
Other | Transferrin soluble receptors | Transferrin soluble receptors | 30 days | |
Other | Glomerular filtration rate | Glomerular filtration rate | 30 days | |
Primary | left ventricular function assessed (LVEF) by CMR. | LVEF assessed by Cardiac Magnetic Resonance | 30 days | |
Secondary | Myocardial iron content assessed by T2* CMR | Myocardial iron content assessed by T2* CMR | 30 days | |
Secondary | myocardial strain assessed by T2* CMR | myocardial strain assessed by T2* CMR | 30 days |
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