Status:
RECRUITING
Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
Lead Sponsor:
Pharmacosmos A/S
Conditions:
Chronic Heart Failure
Iron Deficiencies
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
1900 Patients enrolled
Trial Details
Trial ID
NCT06929806
Start Date
May 1 2025
End Date
December 1 2027
Last Update
July 23 2025
Active Locations (1)
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1
Private clinic
Pasadena, California, United States, 91105