Phase 3Recruiting
Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure (ICONIC-HF)
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
- Sponsor
- Pharmacosmos A/S (Industry)
- Enrolment
- 1,900 planned
- Conditions
- Chronic Heart Failure; Iron Deficiencies
- Interventions
- Ferric Derisomaltose
- Ages
- adults, older adults
- Registry
- NCT06929806
From the registry
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
Primary outcomes
- Number of cardiovascular deaths and hospitalizations for worsening heart failure