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Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

RECRUITINGPhase 3Sponsored by Pharmacosmos A/S
Actively Recruiting
PhasePhase 3
SponsorPharmacosmos A/S
Started2025-05-01
Est. completion2027-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06929806

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Chronic Heart FailureHeart DiseaseIron Deficiencies

Locations1 site

Private clinic
Pasadena, California, 91105
MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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