Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
NCT ID: NCT06929806
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1900 participants
INTERVENTIONAL
2025-05-01
2027-12-01
Brief Summary
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• 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ferric Derisomaltose
50 % of the subjects will be treated with Ferric Derisomaltose 100 mg/mL The ferric derisomaltose dose administered is dependent on the subject's weight and hemoglobin (Hb) level. Subjects treated with ferric derisomaltose will be eligible for re-dosing if transferrin saturation (TSAT) remains below \<25 %
Ferric Derisomaltose
100 mg/mL
Control
50 % of the subjects will receive no IV iron
No interventions assigned to this group
Interventions
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Ferric Derisomaltose
100 mg/mL
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pharmacosmos A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Pharmacosmos Clinical and non-clinical department
Role: STUDY_DIRECTOR
Pharmacosmos A/S
Locations
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Private clinic
Pasadena, California, United States
Countries
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Central Contacts
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Facility Contacts
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MD
Role: primary
Other Identifiers
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P-Monofer-CHF-02
Identifier Type: -
Identifier Source: org_study_id
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