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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
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

Full criteria on ClinicalTrials.gov

Sites (146)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
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BlagoevgradBulgariaRecruiting
Medical Center Medconsult Burgas EOOD
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BurgasBulgariaRecruiting
Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD
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GabrovoBulgariaRecruiting
Multidisciplinary Hospital For Active Treatment Haskovo AD
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HaskovoBulgariaRecruiting
Multi-profile Hospital for Active Treatment Heart and Brain EAD
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PlevenBulgariaRecruiting
University Multiprofessional Hospital For Active Treatment Plovdiv AD
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PlovdivBulgariaRecruiting
Medical centre Kardiohelp EOOD
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SofiaBulgariaRecruiting
National Multidisciplinary Transport Hospital Tsar Boris III
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SofiaBulgariaRecruiting
MHAT National Heart Hospital EAD
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SofiaBulgariaRecruiting
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
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SofiaBulgariaRecruiting
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
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SofiaBulgariaRecruiting
Second Multiprofile Hospital For Active Treatment Sofia EAD
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SofiaBulgariaRecruiting
Medical Center For Specialized Medical Help In Cardiovascular Diseases OOD
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SofiaBulgariaRecruiting
Diagnostic Consultation Center XX-Sofia EOOD
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SofiaBulgariaRecruiting
Medical Center Hera EOOD
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SofiyaBulgariaRecruiting
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaRecruiting
Multiprofile Regional Hospital For Active Treatment Dr. Stefan Cherkezov AD
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Veliko TirnovoBulgariaRecruiting
MEDICUS SERVICES s.r.o.
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Brandýs nad LabemCzechiaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
MUDr. Libor Nechvatal s.r.o.
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Brno-StredCzechiaRecruiting
Fakultni Nemocnice U Sv Anny V Brne
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Brno-StredCzechiaRecruiting
Vojenska Nemocnice Brno
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Brno-ZideniceCzechiaRecruiting
Kardio Chlumec s.r.o.
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Chlumec Nad Cidlinou IvCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Fakultni Nemocnice Plzen
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Plzen 3CzechiaRecruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaRecruiting
Institute for Clinical and Experimental Medicine
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PragueCzechiaRecruiting
Clinical Trials Service s.r.o.
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Uherské HradištěCzechiaRecruiting
KIGE s.r.o.
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ZnojmoCzechiaRecruiting
Region Midtjylland
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Aarhus NDenmarkRecruiting
Copenhagen University Hospital
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Copenhagen OeDenmarkRecruiting
Region Hovedstaden
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FrederiksbergDenmarkRecruiting
Aalborg University Hospital
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GistrupDenmarkRecruiting
Region Hovedstaden
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HerlevDenmarkRecruiting
Region Midtjylland
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HerningDenmarkRecruiting
Holbaek Sygehus
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HolbækDenmarkRecruiting
Region Hovedstaden
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HvidovreDenmarkRecruiting
Odense University Hospital Svendborg
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SvendborgDenmarkRecruiting
Internacionalni medicinski centar PRIORA
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CepinCroatiaRecruiting
Poliklinika Solmed d.o.o.
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Grad ZagrebCroatiaRecruiting
KBC Zagreb
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Grad ZagrebCroatiaRecruiting
Clinical Hospital Dubrava
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Grad ZagrebCroatiaRecruiting
Klinički bolnički centar Osijek
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OsijekCroatiaRecruiting
Specijalna Bolnica Medico
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RijekaCroatiaRecruiting
KBC Split
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SplitCroatiaRecruiting
Opca Bolnica Varazdin
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VarazdinCroatiaRecruiting
Klinicka bolnica Merkur
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ZagrebCroatiaRecruiting
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
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Budapest IIHungaryRecruiting
Semmelweis University
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Budapest XIIHungaryRecruiting
Zugloi Egeszseguegyi Szolgalat
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Budapest XIVHungaryRecruiting
University of Debrecen
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DebrecenHungaryRecruiting
Kistarcsai Flor Ferenc Korhaz
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KistarcsaHungaryRecruiting
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
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NyíregyházaHungaryRecruiting
Belvárosi Egészségház Kft.
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ZalaegerszegHungaryRecruiting
Saramedica MB
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KaunasLithuaniaRecruiting
Saules seimos medicinos centras UAB
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KaunasLithuaniaRecruiting
Inmedica UAB
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KaunasLithuaniaRecruiting
Baltic Medics UAB
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KlaipedaLithuaniaRecruiting
Klinikiniai Sprendimai UAB
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KovnoLithuaniaRecruiting
Respublikine Siauliu ligonine VšĮ
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SiauliaiLithuaniaRecruiting
Inlita UAB
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VilniusLithuaniaRecruiting
Daugavpils regionala slimnica SIA
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DaugavpilsLatviaRecruiting
Liepajas Regionala Slimnica SIA
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LiepajaLatviaRecruiting
Veselibas un socialas aprupes klinika APS SIA
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RigaLatviaRecruiting
Rigas Austrumu kliniska universitates slimnica SIA
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RigaLatviaRecruiting
Rigas 1. slimnica SIA
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RigaLatviaRecruiting
Veselibas Centrs 4 SIA
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RigaLatviaRecruiting
Pauls Stradins Clinical University Hospital
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RigaLatviaRecruiting
Sorlandet Sykehus HF
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ArendalNorwayRecruiting
Vestre Viken HF
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DrammenNorwayRecruiting
Sykehuset Ostfold HF
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GraalumNorwayRecruiting
Sorlandet Sykehus HF
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Kristiansand SNorwayRecruiting
Akershus University Hospital
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LoerenskogNorwayRecruiting
Diakonhjemmet Sykehus AS
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OsloNorwayRecruiting
Oslo Universitetssykehus HF
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OsloNorwayRecruiting
Helse Stavanger HF
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StavangerNorwayRecruiting
St. Olavs hospital HF
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TrondheimNorwayRecruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandRecruiting
Centrum Medyczne "Hipokrates" Elżbieta i Grzegorz Grześk
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BydgoszczPolandRecruiting
Szpital Specjalistyczny Im.J.Dietla W Krakowie
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CracowPolandRecruiting
5 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Krakowie
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CracowPolandRecruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandRecruiting
Uniwersyteckie Centrum Medycyny Morskiej i Tropikalnej
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GdyniaPolandRecruiting
Scanmed Centrum Medyczne Katowice
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KatowicePolandRecruiting
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
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KatowicePolandRecruiting
Specjalistyczna Praktyka Lekarska Ewa Mirek-Bryniarska
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KrakowPolandRecruiting
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ
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LodzPolandRecruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandRecruiting
Grupa Polimedica Sp. z o.o.
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MyszkowPolandRecruiting
Uniwersytecki Szpital Kliniczny w Opolu
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OpolePolandRecruiting
Centrum Medyczne HCP Sp. z o.o.
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PoznanPolandRecruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandRecruiting
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
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PrzemyślPolandRecruiting
Centrum Medyczne Medyk Sp. z o.o. S.K.
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RzeszowPolandRecruiting
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
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TorunPolandRecruiting
American Heart of Poland S.A.
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TychyPolandRecruiting
Międzyleski Szpital Specjalistyczny w Warszawie
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WarsawPolandRecruiting
Balsammedica Sp. z o. o.
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WarsawPolandRecruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandRecruiting
Med-Progress Osrodek Nowoczesnego Leczenia Sp. z o.o.
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WejherowoPolandRecruiting
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
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WroclawPolandRecruiting
Śląskie Centrum Chorób Serca w Zabrzu
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ZabrzePolandRecruiting
American Heart of Poland S.A.
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ZgierzPolandRecruiting
Unidade Local De Saude De Almada-Seixal E.P.E.
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AlmadaPortugalRecruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Unidade Local De Saúde De Lisboa Ocidental E.P.E.
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CarnaxidePortugalRecruiting
Galo Saude Parcerias Cascais S.A.
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CascaisPortugalRecruiting
Unidade Local de Saude do Algarve E.P.E.
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FaroPortugalRecruiting
Centro Hospitalar Do Tamega E Sousa E.P.E.
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GuilhufePortugalRecruiting
Unidade Local De Saude Do Alto Ave E.P.E.
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GuimaraesPortugalRecruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalRecruiting
Hospital Cuf Tejo S.A.
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LisbonPortugalRecruiting
Lusiadas S.A.
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LisbonPortugalRecruiting
Unidade Local de Saude de Sao Joao E.P.E.
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PortoPortugalRecruiting
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
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Vila RealPortugalRecruiting
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
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Baia MareRomaniaRecruiting
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
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BaloteştiRomaniaRecruiting
Spitalul Clinic Judetean de Urgenta Brasov
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BrasovRomaniaRecruiting
Spitalul Clinic Colentina Bucuresti
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BucharestRomaniaRecruiting
Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu",
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BucharestRomaniaRecruiting
Spitalul Clinic De Urgență Sf. Pantelimon București
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BucharestRomaniaRecruiting
Angiocare S.R.L.
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Cluj-NapocaRomaniaRecruiting
Spitalul Clinic De Recuperare
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Cluj-NapocaRomaniaRecruiting
Spitalul Clinic Județean de Urgență Craiova
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CraiovaRomaniaRecruiting
Institutul de Boli Cardiovasculare Prof. Dr. George I.M. Georgescu (IBCV) Iasi
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IașiRomaniaRecruiting
Sal Med S.R.L.
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PitestiRomaniaRecruiting
Spitalul Clinic Judeţean Mureş
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Târgu MureşRomaniaRecruiting
Spitalul Clinic Judetean de Urgenta Targu Mures
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Târgu MureşRomaniaRecruiting
Cabinet Medical Dr Tudoran S.R.L.
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TimisoaraRomaniaRecruiting
Spitalul Clinic Municipal De Urgenta Timisoara
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TimisoaraRomaniaRecruiting
University Clinic Golnik
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GolnikSloveniaNot yet recruiting
Splosna Bolnisnica Izola Ospedale Generale Isola
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Izola/isolaSloveniaNot yet recruiting
Splosna Bolnisnica Murska Sobota
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Murska SobotaSloveniaNot yet recruiting
General Hospital Trbovlje
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TrbovljeSloveniaNot yet recruiting
Narodny ustav srdcovych a cievnych chorob, a.s
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BratislavaSlovakiaRecruiting
Dolnooravska Nemocnica S Poliklinikou Mudr. L. N. Jegeho
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Dolny KubinSlovakiaRecruiting
Medical Group Kosice s.r.o
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KošiceSlovakiaRecruiting
Cardio D&R s.r.o. Kosice
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KošiceSlovakiaRecruiting
Vychodoslovensky Ustav Srdcovych A Cievnych Chorob a.s.
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Kosice - ZapadSlovakiaRecruiting
Kardio 1 s.r.o.
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Lucenec Banska BystricSlovakiaRecruiting
Univerzitna nemocnica Martin
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MartinSlovakiaRecruiting
KVC Kardiovaskularne Centrum s.r.o.
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MartinSlovakiaRecruiting
Medikard s.r.o.
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PresovSlovakiaRecruiting
Nemocnica s poliklinikou sv. Barbory Roznava a.s.
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RoznavaSlovakiaRecruiting
Interna SK s.r.o.
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SvidníkSlovakiaRecruiting
Private clinic
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PasadenaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.