NCT06929806RecruitingPhase 3
Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
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
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1900 (estimated)
- First submitted
- 8 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Pharmacosmos A/S
- Diseases
- Heart failure
- NCT number
- NCT06929806
- EU CT number
- 2024-519059-28-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1900
- From 1 May 2025 to the primary completion date, 1 Dec 2027
- 146 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months
- Treatment with radiotherapy or chemotherapy
Other illness
- Planned cardiac surgery or revascularization or cardiac device implantation
Other
- Pregnant or nursing women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (146)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD Coordinator of this site? Confirm its status | Blagoevgrad | Bulgaria | Recruiting |
| Medical Center Medconsult Burgas EOOD Coordinator of this site? Confirm its status | Burgas | Bulgaria | Recruiting |
| Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD Coordinator of this site? Confirm its status | Gabrovo | Bulgaria | Recruiting |
| Multidisciplinary Hospital For Active Treatment Haskovo AD Coordinator of this site? Confirm its status | Haskovo | Bulgaria | Recruiting |
| Multi-profile Hospital for Active Treatment Heart and Brain EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| University Multiprofessional Hospital For Active Treatment Plovdiv AD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Medical centre Kardiohelp EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| National Multidisciplinary Transport Hospital Tsar Boris III Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| MHAT National Heart Hospital EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Second Multiprofile Hospital For Active Treatment Sofia EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Medical Center For Specialized Medical Help In Cardiovascular Diseases OOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Diagnostic Consultation Center XX-Sofia EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Multiprofile Regional Hospital For Active Treatment Dr. Stefan Cherkezov AD Coordinator of this site? Confirm its status | Veliko Tirnovo | Bulgaria | Recruiting |
| MEDICUS SERVICES s.r.o. Coordinator of this site? Confirm its status | Brandýs nad Labem | Czechia | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| MUDr. Libor Nechvatal s.r.o. Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Recruiting |
| Fakultni Nemocnice U Sv Anny V Brne Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Recruiting |
| Vojenska Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Zidenice | Czechia | Recruiting |
| Kardio Chlumec s.r.o. Coordinator of this site? Confirm its status | Chlumec Nad Cidlinou Iv | Czechia | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Fakultni Nemocnice Plzen Coordinator of this site? Confirm its status | Plzen 3 | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Institute for Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Clinical Trials Service s.r.o. Coordinator of this site? Confirm its status | Uherské Hradiště | Czechia | Recruiting |
| KIGE s.r.o. Coordinator of this site? Confirm its status | Znojmo | Czechia | Recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Copenhagen University Hospital Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Frederiksberg | Denmark | Recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Gistrup | Denmark | Recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Herning | Denmark | Recruiting |
| Holbaek Sygehus Coordinator of this site? Confirm its status | Holbæk | Denmark | Recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Hvidovre | Denmark | Recruiting |
| Odense University Hospital Svendborg Coordinator of this site? Confirm its status | Svendborg | Denmark | Recruiting |
| Internacionalni medicinski centar PRIORA Coordinator of this site? Confirm its status | Cepin | Croatia | Recruiting |
| Poliklinika Solmed d.o.o. Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Recruiting |
| KBC Zagreb Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Recruiting |
| Clinical Hospital Dubrava Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Recruiting |
| Klinički bolnički centar Osijek Coordinator of this site? Confirm its status | Osijek | Croatia | Recruiting |
| Specijalna Bolnica Medico Coordinator of this site? Confirm its status | Rijeka | Croatia | Recruiting |
| KBC Split Coordinator of this site? Confirm its status | Split | Croatia | Recruiting |
| Opca Bolnica Varazdin Coordinator of this site? Confirm its status | Varazdin | Croatia | Recruiting |
| Klinicka bolnica Merkur Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz Coordinator of this site? Confirm its status | Budapest II | Hungary | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest XII | Hungary | Recruiting |
| Zugloi Egeszseguegyi Szolgalat Coordinator of this site? Confirm its status | Budapest XIV | Hungary | Recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Kistarcsai Flor Ferenc Korhaz Coordinator of this site? Confirm its status | Kistarcsa | Hungary | Recruiting |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Recruiting |
| Belvárosi Egészségház Kft. Coordinator of this site? Confirm its status | Zalaegerszeg | Hungary | Recruiting |
| Saramedica MB Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
| Saules seimos medicinos centras UAB Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
| Inmedica UAB Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
| Baltic Medics UAB Coordinator of this site? Confirm its status | Klaipeda | Lithuania | Recruiting |
| Klinikiniai Sprendimai UAB Coordinator of this site? Confirm its status | Kovno | Lithuania | Recruiting |
| Respublikine Siauliu ligonine VšĮ Coordinator of this site? Confirm its status | Siauliai | Lithuania | Recruiting |
| Inlita UAB Coordinator of this site? Confirm its status | Vilnius | Lithuania | Recruiting |
| Daugavpils regionala slimnica SIA Coordinator of this site? Confirm its status | Daugavpils | Latvia | Recruiting |
| Liepajas Regionala Slimnica SIA Coordinator of this site? Confirm its status | Liepaja | Latvia | Recruiting |
| Veselibas un socialas aprupes klinika APS SIA Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Rigas Austrumu kliniska universitates slimnica SIA Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Rigas 1. slimnica SIA Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Veselibas Centrs 4 SIA Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Sorlandet Sykehus HF Coordinator of this site? Confirm its status | Arendal | Norway | Recruiting |
| Vestre Viken HF Coordinator of this site? Confirm its status | Drammen | Norway | Recruiting |
| Sykehuset Ostfold HF Coordinator of this site? Confirm its status | Graalum | Norway | Recruiting |
| Sorlandet Sykehus HF Coordinator of this site? Confirm its status | Kristiansand S | Norway | Recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Recruiting |
| Diakonhjemmet Sykehus AS Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Oslo Universitetssykehus HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Helse Stavanger HF Coordinator of this site? Confirm its status | Stavanger | Norway | Recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Centrum Medyczne "Hipokrates" Elżbieta i Grzegorz Grześk Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Szpital Specjalistyczny Im.J.Dietla W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| 5 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Uniwersyteckie Centrum Medycyny Morskiej i Tropikalnej Coordinator of this site? Confirm its status | Gdynia | Poland | Recruiting |
| Scanmed Centrum Medyczne Katowice Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Specjalistyczna Praktyka Lekarska Ewa Mirek-Bryniarska Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Grupa Polimedica Sp. z o.o. Coordinator of this site? Confirm its status | Myszkow | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny w Opolu Coordinator of this site? Confirm its status | Opole | Poland | Recruiting |
| Centrum Medyczne HCP Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Wojewodzki Szpital im Sw Ojca Pio w Przemyslu Coordinator of this site? Confirm its status | Przemyśl | Poland | Recruiting |
| Centrum Medyczne Medyk Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Rzeszow | Poland | Recruiting |
| Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| American Heart of Poland S.A. Coordinator of this site? Confirm its status | Tychy | Poland | Recruiting |
| Międzyleski Szpital Specjalistyczny w Warszawie Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Balsammedica Sp. z o. o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Med-Progress Osrodek Nowoczesnego Leczenia Sp. z o.o. Coordinator of this site? Confirm its status | Wejherowo | Poland | Recruiting |
| 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Śląskie Centrum Chorób Serca w Zabrzu Coordinator of this site? Confirm its status | Zabrze | Poland | Recruiting |
| American Heart of Poland S.A. Coordinator of this site? Confirm its status | Zgierz | Poland | Recruiting |
| Unidade Local De Saude De Almada-Seixal E.P.E. Coordinator of this site? Confirm its status | Almada | Portugal | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Unidade Local De Saúde De Lisboa Ocidental E.P.E. Coordinator of this site? Confirm its status | Carnaxide | Portugal | Recruiting |
| Galo Saude Parcerias Cascais S.A. Coordinator of this site? Confirm its status | Cascais | Portugal | Recruiting |
| Unidade Local de Saude do Algarve E.P.E. Coordinator of this site? Confirm its status | Faro | Portugal | Recruiting |
| Centro Hospitalar Do Tamega E Sousa E.P.E. Coordinator of this site? Confirm its status | Guilhufe | Portugal | Recruiting |
| Unidade Local De Saude Do Alto Ave E.P.E. Coordinator of this site? Confirm its status | Guimaraes | Portugal | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Hospital Cuf Tejo S.A. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Lusiadas S.A. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E. Coordinator of this site? Confirm its status | Vila Real | Portugal | Recruiting |
| Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare Coordinator of this site? Confirm its status | Baia Mare | Romania | Recruiting |
| Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu Coordinator of this site? Confirm its status | Baloteşti | Romania | Recruiting |
| Spitalul Clinic Judetean de Urgenta Brasov Coordinator of this site? Confirm its status | Brasov | Romania | Recruiting |
| Spitalul Clinic Colentina Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu", Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic De Urgență Sf. Pantelimon București Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Angiocare S.R.L. Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Spitalul Clinic De Recuperare Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Spitalul Clinic Județean de Urgență Craiova Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| Institutul de Boli Cardiovasculare Prof. Dr. George I.M. Georgescu (IBCV) Iasi Coordinator of this site? Confirm its status | Iași | Romania | Recruiting |
| Sal Med S.R.L. Coordinator of this site? Confirm its status | Pitesti | Romania | Recruiting |
| Spitalul Clinic Judeţean Mureş Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Recruiting |
| Spitalul Clinic Judetean de Urgenta Targu Mures Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Recruiting |
| Cabinet Medical Dr Tudoran S.R.L. Coordinator of this site? Confirm its status | Timisoara | Romania | Recruiting |
| Spitalul Clinic Municipal De Urgenta Timisoara Coordinator of this site? Confirm its status | Timisoara | Romania | Recruiting |
| University Clinic Golnik Coordinator of this site? Confirm its status | Golnik | Slovenia | Not yet recruiting |
| Splosna Bolnisnica Izola Ospedale Generale Isola Coordinator of this site? Confirm its status | Izola/isola | Slovenia | Not yet recruiting |
| Splosna Bolnisnica Murska Sobota Coordinator of this site? Confirm its status | Murska Sobota | Slovenia | Not yet recruiting |
| General Hospital Trbovlje Coordinator of this site? Confirm its status | Trbovlje | Slovenia | Not yet recruiting |
| Narodny ustav srdcovych a cievnych chorob, a.s Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
| Dolnooravska Nemocnica S Poliklinikou Mudr. L. N. Jegeho Coordinator of this site? Confirm its status | Dolny Kubin | Slovakia | Recruiting |
| Medical Group Kosice s.r.o Coordinator of this site? Confirm its status | Košice | Slovakia | Recruiting |
| Cardio D&R s.r.o. Kosice Coordinator of this site? Confirm its status | Košice | Slovakia | Recruiting |
| Vychodoslovensky Ustav Srdcovych A Cievnych Chorob a.s. Coordinator of this site? Confirm its status | Kosice - Zapad | Slovakia | Recruiting |
| Kardio 1 s.r.o. Coordinator of this site? Confirm its status | Lucenec Banska Bystric | Slovakia | Recruiting |
| Univerzitna nemocnica Martin Coordinator of this site? Confirm its status | Martin | Slovakia | Recruiting |
| KVC Kardiovaskularne Centrum s.r.o. Coordinator of this site? Confirm its status | Martin | Slovakia | Recruiting |
| Medikard s.r.o. Coordinator of this site? Confirm its status | Presov | Slovakia | Recruiting |
| Nemocnica s poliklinikou sv. Barbory Roznava a.s. Coordinator of this site? Confirm its status | Roznava | Slovakia | Recruiting |
| Interna SK s.r.o. Coordinator of this site? Confirm its status | Svidník | Slovakia | Recruiting |
| Private clinic Coordinator of this site? Confirm its status | Pasadena | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.