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

Study acronym: COMBINED-HF
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Interventions: Iron Carboxymaltose (Drug) to Dapagliflozin 10mg Tab (Drug), Iron Carboxymaltose (Drug), Placebo of Dapagliflozin (Drug), Placebo of Iron Carboxymaltose (Drug)v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06434025
Lead Sponsor Hospital de Clinicas de Porto Alegre
Collaborators: Vifor Pharma
Conditions
(from sponsor)		 Heart Failure, Systolic, Iron Deficiencies
Related terms Heart Failure, Heart Failure, Systolic, Iron Deficiencies
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov