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

PHASE4RecruitingINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

December 21, 2026

Conditions
Heart FailureIron Deficiency
Interventions
DRUG

High-dose ferric derisomaltose

"After baseline assessment, participants will be randomized in a 1:1 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 follow-up.~In the high-dose group, participants will receive repeat iron dosing as long as the serum ferritin was not \>700 ng/mL, or if TSAT was not \>40% during follow-up."

DRUG

Low-dose ferric derisomaltose

In the low-dose group, participants will receive repeat iron dosing if ferritin \<100 ng/mL or if ferritin 100-300 ng/mL and TSAT \>20% during follow-up.

Trial Locations (1)

100044

RECRUITING

China-Japan Friendship Hospital, Beijing

All Listed Sponsors
lead

China-Japan Friendship Hospital

OTHER