Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427343
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-19
Brief Title:
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Sponsor:
China-Japan Friendship Hospital
Organization:
China-Japan Friendship Hospital
Study Overview
Official Title:
The Effects of Low-dose Versus High-dose Intravenous Iron Therapy With Ferric Derisomaltose in Patients With Chronic Heart Failure and Iron Deficiency a Randomized Open-label Blind Endpoint Trial IRONDOSE
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRONDOSE
Brief Summary:
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
Detailed Description:
Iron deficiency is a common and important comorbidity in heart failure Randomized controlled trials have consistently demonstrated a beneficial effect of IV iron on exercise capacity and quality of life in iron-deficient patients with HF and reduced ejection fraction However these randomized controlled trials exhibit striking heterogeneity in targeting levels for maintenance strategies of IV iron repletion Some studies FERRIC-HF FAIR-HF withheld intravenous iron in cases of ferritin 800 ngmL hemoglobin 160 gdL or transferrin saturation TSAT 50 while other studies HEART-FID IRONMAN focused on targeting levels that are simply above the definition of iron deficiency Additionally the PIVOTAL trial showed that high-dose IV iron decreased recurrent heart failure events in patients undergoing hemodialysis compared to a lower-dose regimen Whether functional outcomes differ between those on lower versus higher iron repletion targets among patients with heart failure remains unknown This study will help us address this question
This is an investigator-initiated prospective randomized open-label blind endpoint study to assess the effects of high-dose IV iron repletion compared to a low-dose IV iron repletion on 12-month change in peak oxygen uptake VO2 for patients with chronic heart failure and concomitant iron deficiency
Patients with chronic heart failure and iron deficiency will be enrolled and randomized in a 11 ratio to receive a high-dose IV iron regimen and a low-dose IV iron regimen After the initial iron repletion ferritin concentration and TSAT were measured every three months and the results used to determine the dose of ferric derisomaltose during the follow-up period In the high dose group iron dosing will repeat as long as the serum ferritin was not 700ngmL or if TSAT was not 40 Patients in the low dose group will receive repeat iron dosing if ferritin 100 ngmL or if ferritin 100-300 ngmL and TSAT 20 in line with criteria for iron deficiency in current guidelines
This is an investigator-initiated prospective randomized open-label blind endpoint study to assess the effects of high-dose IV iron repletion compared to a low-dose IV iron repletion on 12-month change in peak oxygen uptake VO2 for patients with chronic heart failure and concomitant iron deficiency
Patients with chronic heart failure and iron deficiency will be enrolled and randomized in a 11 ratio to receive a high-dose IV iron regimen and a low-dose IV iron regimen After the initial iron repletion ferritin concentration and TSAT were measured every three months and the results used to determine the dose of ferric derisomaltose during the follow-up period In the high dose group iron dosing will repeat as long as the serum ferritin was not 700ngmL or if TSAT was not 40 Patients in the low dose group will receive repeat iron dosing if ferritin 100 ngmL or if ferritin 100-300 ngmL and TSAT 20 in line with criteria for iron deficiency in current guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None