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

Launched by PHARMACOSMOS A/S · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a type of intravenous (IV) iron treatment called ferric derisomaltose can help improve symptoms in people with chronic heart failure who also have low iron levels. The main goal is to find out if this treatment can reduce the number of patients who need to be hospitalized or who experience serious heart-related issues. Participants will be randomly assigned to receive either the ferric derisomaltose treatment or no treatment at all, but everyone will receive standard care for their heart condition.

To be eligible for the trial, participants need to be at least 18 years old, have chronic heart failure that makes them feel tired or short of breath during daily activities, and have a specific measurement of heart function that is lower than normal. They should also have low iron levels in their blood. Participants will visit the study site several times and have a few phone or video calls to check on their progress. This trial is not yet recruiting, so interested individuals should stay tuned for more information about how to join.

Gender

ALL

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