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Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 18 years or older * Both women and men can join * Heart failure that causes fatigue, shortness of breath, or other symptoms during physical activity * Have left ventricle (chamber) ejection fraction (pumping ability) that is 45% or less * Have low iron levels in the blood * New York Heart Association (NYHA) Heart Failure Classification II, III or IV Exclusion Criteria: * Planned cardiac surgery or revascularization or cardiac device implantation * Pregnant or nursing women * Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months * Treatment with radiotherapy or chemotherapy
About the study
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
What is being tested
- Ferric Derisomaltose (drug)
Sponsor: Pharmacosmos A/S · Participants: 1,900 · Started: May 1, 2025
Contact the study team
- Pharmacosmos Clinical and non-clinical Department · Phone: +45 5948 5959
Official record on ClinicalTrials.gov — NCT06929806
Locations in the U.S.
| California | Private clinic, Pasadena |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.