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Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
Sponsor: Pharmacosmos A/S
Summary
The goal of this clinical trial is to learn if the IV Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. The main question it aims to answer is: • How many participants are admitted to the hospital or die from a disease in the heart or blood vessels Researchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works. Participants will: * Be randomized 50/50 to either treatment with Ferric derisomaltose or to no treatment with ferric derisomaltose * All participants receives standard of care * Visit site 4-5 times and have 7 video/phone-calls
Official title: A Phase III, Randomized, Open-label, Blinded Endpoint, Comparative Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1900
Start Date
2025-05-01
Completion Date
2027-12-01
Last Updated
2025-07-23
Healthy Volunteers
No
Conditions
Interventions
Ferric Derisomaltose
100 mg/mL
Locations (1)
Private clinic
Pasadena, California, United States