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Taking people in PolandPhase 3

Iron infusion for people with chronic heart failure and low iron

Tests ferric derisomaltose given into a vein in heart failure with iron deficiency.

Plain-language title generated from the registry record
Registry title: Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

Key facts

Where
Bialystok, Bydgoszcz, Cracow, Gdansk, Gdynia, Katowice, Krakow, Lodz, Lublin, Myszkow, Opole, Poznan, Przemyśl, Rzeszow, Torun, Tychy, Warsaw, Wejherowo, Wroclaw, Zabrze, and Zgierz, PolandSee the 26 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic heart failure who have symptoms and low iron levels in the blood.

Age
18 years or older
Sex
Women and men can join
Disease stage
Heart failure with symptoms during physical activity (NYHA class II, III or IV), and a left ventricle ejection fraction (pumping ability) of 45% or less
Earlier treatment
Cannot have had iron through the vein or by injection in the muscle within the past 6 months
Biomarker or test result
Low iron levels in the blood

Main reasons for not taking part

  • Planned cardiac surgery, revascularization or cardiac device implantation
  • Pregnant or nursing women
  • Iron through the vein or muscle injection within the past 6 months
  • Treatment with radiotherapy or chemotherapy

Read by machine on 12 November 2026.

Where in Poland

  • Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, PolandTaking people
  • Centrum Medyczne "Hipokrates" Elżbieta i Grzegorz GrześkBydgoszcz, PolandTaking people
  • 5 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej W KrakowieCracow, PolandTaking people
  • Szpital Specjalistyczny Im.J.Dietla W KrakowieCracow, PolandTaking people
  • Copernicus Podmiot Leczniczy Sp. z o.oGdansk, PolandTaking people
  • Uniwersyteckie Centrum Medycyny Morskiej i TropikalnejGdynia, PolandTaking people
  • Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W KatowicachKatowice, PolandTaking people
  • Scanmed Centrum Medyczne KatowiceKatowice, PolandTaking people
  • Specjalistyczna Praktyka Lekarska Ewa Mirek-BryniarskaKrakow, PolandTaking people
  • Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZLodz, PolandTaking people
  • Uniwersytecki Szpital Kliniczny nr 4 w LublinieLublin, PolandTaking people
  • Grupa Polimedica Sp. z o.o.Myszkow, PolandTaking people
  • Uniwersytecki Szpital Kliniczny w OpoluOpole, PolandTaking people
  • Centrum Medyczne HCP Sp. z o.o.Poznan, PolandTaking people
  • Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, PolandTaking people
  • Wojewodzki Szpital im Sw Ojca Pio w PrzemysluPrzemyśl, PolandTaking people
  • Centrum Medyczne Medyk Sp. z o.o. S.K.Rzeszow, PolandTaking people
  • Wojewodzki Szpital Zespolony im. L. Rydygiera w ToruniuTorun, PolandTaking people
  • American Heart of Poland S.A.Tychy, PolandTaking people
  • Balsammedica Sp. z o. o.Warsaw, PolandTaking people
  • Międzyleski Szpital Specjalistyczny w WarszawieWarsaw, PolandTaking people
  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i AdministracjiWarsaw, PolandTaking people
  • Med-Progress Osrodek Nowoczesnego Leczenia Sp. z o.o.Wejherowo, PolandTaking people
  • 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We WroclawiuWroclaw, PolandTaking people
  • Śląskie Centrum Chorób Serca w ZabrzuZabrze, PolandTaking people
  • American Heart of Poland S.A.Zgierz, PolandTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

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.

ClinicalTrials.gov NCT06929806 · EU CTIS 2024-519059-28-00