Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
Recruiting
Phase 3
Interventional Study
Chronic Heart Failure
Iron Deficiencies
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,900 (estimated)
- Sponsor
- Pharmacosmos A/S · Industry
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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 f…
Trial Locations
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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
* Ne…
Contacts