RecruitingPhase 3NCT06929806

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

Sponsor

Pharmacosmos A/S

Enrollment

1,900 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Iron Deficiencies Chronic Heart Failure

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether giving intravenous iron (ferric derisomaltose) to heart failure patients with low iron levels improves their symptoms and quality of life compared to receiving no iron treatment. **You may be eligible if...** - You are 18 or older (men and women) - You have heart failure causing fatigue, shortness of breath, or other symptoms with activity - Your heart's pumping ability (ejection fraction) is 45% or less - You have low iron levels in your blood - Your symptoms are NYHA class II, III, or IV **You may NOT be eligible if...** - You are planning heart surgery, a stent procedure, or a device implant - You are pregnant or nursing - You received IV or injectable iron in the past 6 months - You are currently receiving chemotherapy or radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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