drugset / Trial / NCT06434025

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

NCT06434025

Phase 3 Not yet recruiting 99 enrolled Hospital de Clinicas de Porto Alegre Vifor Pharma · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2024-05-24
Primary completion
2026-05-24
Completion
2026-11-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 10 mg Oral
Subject Ferric carboxymaltose Other / unclassified 500 mg Intravenous