Clinical Trial

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

Study acronym: COMBINED-HF
Not Yet Recruiting Phase 3
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Record status
This record was last updated June 3, 2024 (before its estimated May 24, 2026 completion). Its status may not reflect the trial's current state.
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 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-05-23.
Trial Details
NCT Number NCT06434025
Lead Sponsor Hospital de Clinicas de Porto Alegre
Collaborators: Vifor Pharma
Conditions Heart Failure, Systolic, Iron Deficiencies
Enrollment 99 participants
Start Date 2024-05-24
Primary Completion 2026-05-24 (estimated)
Study Completion 2026-11-24 (estimated)
Updated on ClinicalTrials.gov 2024-06-03