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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharmacosmos A/S

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ferric Derisomaltose

Treatment groups

1,900 Participants
are divided into 2 treatment groups

Sponsors and collaborators