Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
Key facts
- Where
- Baia Mare, Baloteşti, Brasov, Bucharest, Cluj-Napoca, Craiova, Iași, Pitesti, Târgu Mureş, and Timisoara, RomaniaSee the 15 sites
- Phase
- Phase 3
Where in Romania
- Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia MareBaia Mare, RomaniaTaking people
- Spitalul Clinic De Urgenta Prof Dr Agrippa IonescuBaloteşti, RomaniaTaking people
- Spitalul Clinic Judetean de Urgenta BrasovBrasov, RomaniaTaking people
- Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu",Bucharest, RomaniaTaking people
- Spitalul Clinic Colentina BucurestiBucharest, RomaniaTaking people
- Spitalul Clinic De Urgență Sf. Pantelimon BucureștiBucharest, RomaniaTaking people
- Angiocare S.R.L.Cluj-Napoca, RomaniaTaking people
- Spitalul Clinic De RecuperareCluj-Napoca, RomaniaTaking people
- Spitalul Clinic Județean de Urgență CraiovaCraiova, RomaniaTaking people
- Institutul de Boli Cardiovasculare Prof. Dr. George I.M. Georgescu (IBCV) IasiIași, RomaniaTaking people
- Sal Med S.R.L.Pitesti, RomaniaTaking people
- Spitalul Clinic Judetean de Urgenta Targu MuresTârgu Mureş, RomaniaTaking people
- Spitalul Clinic Judeţean MureşTârgu Mureş, RomaniaTaking people
- Cabinet Medical Dr Tudoran S.R.L.Timisoara, RomaniaTaking people
- Spitalul Clinic Municipal De Urgenta TimisoaraTimisoara, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pharmacosmos A/S
- Trial code
- NCT06929806EU 2024-519059-28-00
- Record updated
- 5 October 2026
- Original description
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:Read full original descriptionShow less
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
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
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: Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months; Treatment with radiotherapy or chemotherapy; Planned cardiac surgery or revascularization or cardiac device implantation; Pregnant or nursing women.