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The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency

Study acronym: IRONDOSE
StatusRecruiting
PhasePhase 4
Started2023-10-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 19, 2025 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-02-15
minor
Study Status v2
Re-verified, no change to tracked fields
2024-06-03
minor
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Eligibility criteria-51 characters
Inclusion Criteria: Age &gt;>18 years. Left ventricular ejection fraction (LVEF) &lt;<50% within 2 years prior to planned randomization (assessed [...] randomization. a. For patients in sinus rhythm: NT- proBNP &gt;>300 pg/mL or BNP &gt;>100 pg/mL. b. For patients in atrial fibrillation: NT-proBNP &gt;>600 pg/mL or BNP &gt;>200 pg/mL. Subjects with stable CHF (NYHA II/III functional [...] t 2 weeks (with the exception of diuretics). Serum ferritin &lt;<100 ng/mL or serum ferritin 100-300 ng/mL and TSAT &gt;<20%. Able and willing to perform a CPET at the time of rando [...] to provide informed consent. Exclusion [...]
Secondary endpoints13 entries, revised
Change in VO2 at ventilatory threshold (ml/min) Change in heart rate at peak exercise (bpm) Change in 6-minute walking distance (m) Change in concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP, pg/mL) Change in left ventricular systolicejection functionfraction (LVEF, %) Change in left ventricular global longitudinal stress (LVGLS, %)
Primary endpoints1 entry, revised
Change in peak VO2 (ml/min/kg)
Study description-21 characters
[...] HF, FAIR-HF) withheld intravenous iron in cases of ferritin &gt;>800 ng/mL, hemoglobin &gt;>16.0 g/dL, or transferrin saturation (TSAT) &gt;>50%, while other studies (HEART-FID, IRONMAN) focused on tar [...] on dosing will repeat as long as the serum ferritin was not &gt;>700ng/mL, or if TSAT was not &gt;>40%. Patients in the low dose group will receive repeat iron dosing if ferritin &lt;<100 ng/mL, or if ferritin 100-300 ng/mL and TSAT &lt;<20%, in line with criteria for iron deficiency in current guidelines.
Study sitescontacts updated at 1 of 1 site
Study titlerevised
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy withWith Ferric DerisomaltoseDerisomaltOSE in Patients withWith Chronic Heart Failure and Iron Deficiency
2024-05-19
minor
Original filing
This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target.
Trial Details
NCT Number NCT06427343
Lead Sponsor China-Japan Friendship Hospital
Conditions Heart Failure, Iron Deficiency
Enrollment 114 participants
Start Date 2023-10-01
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-12-21 (estimated)
Updated on ClinicalTrials.gov 2025-02-19