New drug aims to reverse heart damage in failure patients
NCT ID NCT06979375
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a potential new medicine called CDR132L in 200 people with heart failure and an enlarged heart. Participants receive either CDR132L or a placebo by IV every 4 weeks for 48 weeks. The goal is to see if the drug can improve heart structure and function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CDR132L (a potential new medicine given as an intravenous infusion every 4 weeks for 48 weeks)
- What this could lead to
- If it works, this could point toward a new treatment that improves heart structure and function in people with heart failure.
- What could go wrong
- This is a Phase 2 trial with only 200 participants, so it is still early. The drug may not show benefit over placebo, and there may be unknown side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 84 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 40-84 years (both inclusive) at the time of signing the informed consent. * Documented symptomatic heart failure (HF) diagnosed greater than or equal to (≥) 180 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association class II-III at screening. * Clinically stable and on optimized doses and unchanged drug classes of guideline-directed HF therapy ≥ 45 days prior to randomisation. * Left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) as assessed by echocardiography at screening, measured by central laboratory. * Left ventricular hypertrophy or left ventricular dilatation assessed by echocardiography at screening measured by central laboratory with any of the following: 1. LVMi greater than (\>)88 g/m\^2 for female participants and \>102 g/m\^2 for male participants using the truncated ellipsoid method. 2. LVMi \>95 g/m\^2 for female participants and \>115 g/m\^2 for male participants, using the linear method (cube formula). 3. Left ventricular end-diastolic diameter indexed to body surface area (LVEDDi) \>3.1 cm/m\^2 for female participants and \>3.0 cm/m\^2 for male participants. * Body mass index 18.5-40 kilogram per meter square (kg/m\^2) (both inclusive) and body weight less than or equal to (≤) 140 kilogram (kg). Body mass index is calculated in the electronic case report form based on height and body weight at the screening visit (visit 1). * N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 300 picograms per milliliter (pg/mL); NT-proBNP ≥600 pg/mL if atrial fibrillation/flutter is present at time of screening, measured by central laboratory. Exclusion Criteria: * Estimated Glomerular Filtration Rate (eGFR) less than (\<) 30 milliliter/minute/ 1.73-meter square (mL/min/1.73 m\^2) at time of screening, measured by central laboratory. * Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator,within 90 days prior to randomisation. * Myocardial infarction, unstable angina pectoris or HF hospitalization within 30 days prior to screening. * Participants receiving intravenous HF medications within 45 days prior to randomisation. * Planned coronary revascularization, pacemaker/cardioverter-defibrillator/cardiac resynchronization therapy (CRT) implantation, ablation of cardiac arrythmias or valve repair/replacement at the time of randomisation. * Stroke or transient ischemic attack within 12 months prior to randomisation. * Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator. * Known history of severe liver disease and/or alanine aminotransferase or aspartate aminotransferase greater than (\>) 2.5x upper limit of normal at screening, measured by central laboratory. * Known genetic (or highly suspected due to family history) cause of increased cardiac mass (including dilated cardiomyopathy, Fabry disease and likely pathogenic or pathogenic variants within hypertrophic cardiomyopathy (HCM). * Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
86 sites in 10 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
NOT_YET_RECRUITINGLublin, Lublin Voivodeship, 20-049, Poland
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4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
RECRUITINGWroclaw, Lower Silesian Voivodeship, 50-981, Poland
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American Heart of Poland S.A.
NOT_YET_RECRUITINGBielsko-Biala, 43-316, Poland
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AmsterdamUMC AMC
RECRUITINGAmsterdam, 1105 AZ, Netherlands
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Arneja Heart & Multispeciality Hospital
RECRUITINGNagpur, Maharashtra, 440010, India
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Arneja Heart & Multispeciality Hospital
NOT_YET_RECRUITINGNagpur, Maharashtra, 440010, India
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Charité - Campus Benjamin Franklin - Klinik für Kardiologie
NOT_YET_RECRUITINGBerlin, 12203, Germany
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Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU)
RECRUITINGBerlin, 13353, Germany
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Chungbuk National University Hospital
RECRUITINGCheongju-si, 28644, South Korea
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Concord Repatriation General Hospital - Cardiology Department
RECRUITINGConcord, New South Wales, 2139, Australia
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Dayanand Medical College & Hospital
RECRUITINGLudhiana, Punjab, 141001, India
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Erasmus MC
RECRUITINGRotterdam, 3015 GD, Netherlands
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Fakultní Nemocnice Ostrava
RECRUITINGOstrava-Poruba, 708 52, Czechia
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Fakultní nemocnice u sv. Anny v Brně
COMPLETEDBrno, 602 00, Czechia
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Fiona Stanley Hospital - Cardiology
RECRUITINGMurdoch, Western Australia, 6150, Australia
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Flinders Medical Centre
RECRUITINGBedford Park, South Australia, 5042, Australia
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G B Pant Institute of Postgraduate Medical Education and Research
RECRUITINGNew Delhi, National Capital Territory of Delhi, 110002, India
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H. Clinico Univ. Virgen de la Victoria
COMPLETEDMálaga, 29010, Spain
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Hospital Clinico Universitario de Valencia
RECRUITINGValencia, 46010, Spain
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Hospital Ramón y Cajal_Cardiología
NOT_YET_RECRUITINGMadrid, 28034, Spain
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Hospital Univ. Virgen de la Arrixaca
RECRUITINGEl Palmar, Murcia, 30120, Spain
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Hospital Univ. de Gerona Doctor Josep Trueta
RECRUITINGGirona, Catalonia, 17007, Spain
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Hospital Univ. de Gran Canaria Doctor Negrín
NOT_YET_RECRUITINGLas Palmas de Gran Canaria, 35010, Spain
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Hospital Universitario La Paz
RECRUITINGMadrid, 28046, Spain
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Hospital Universitario Puerta de Hierro Majadahonda
NOT_YET_RECRUITINGMajadahonda, 28222, Spain
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Hospital Universitario San Cecilio
RECRUITINGGranada, Andalusia, 18016, Spain
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Hospital Universitario Virgen del Rocío
NOT_YET_RECRUITINGSeville, 41013, Spain
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Hospital Virgen de la Arrixaca
NOT_YET_RECRUITINGEl Palmar, 30120, Spain
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Hospital de Dénia_Cardiología
COMPLETEDDenia, 03700, Spain
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Hospital del Mar
RECRUITINGBarcelona, 08003, Spain
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Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology
RECRUITINGHimeji-shi, Hyogo, 670-8560, Japan
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IKEM
RECRUITINGPrague, 140 21, Czechia
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JA Shizuoka Kohseiren Enshu Hospital_ Cardiology
NOT_YET_RECRUITINGHamamatsu-shi, Shizuoka, 430-0929, Japan
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Kagawa University Hospital_Cardiology
COMPLETEDKita-gun, Kagawa, 761-0793, Japan
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Keimyung University Dongsan Hospital
RECRUITINGDaegu, 42601, South Korea
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Kings College Hospital
RECRUITINGLondon, SE5 9RS, United Kingdom
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Kobe City Medical Center General Hospital_Cardiology
RECRUITINGKobe-shi, Hyogo, 650-0047, Japan
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Korea University Anam Hospital
RECRUITINGSeoul, 02841, South Korea
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Korea University Guro Hospital
RECRUITINGSeoul, 08308, South Korea
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Korea University Guro Hospital
NOT_YET_RECRUITINGSeoul, 08308, South Korea
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Krakowski Szpital Specjalistyczny im. Jana Pawla II
RECRUITINGKrakow, 31-202, Poland
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Lisie Hospital
RECRUITINGKochi, Kerala, 682018, India
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Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine
RECRUITINGOsaka-shi, Osaka, 530-8480, Japan
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Medizinische Hochschule Hannover - Kardiologie und Angiologie
RECRUITINGHanover, 30625, Germany
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NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine
RECRUITINGBunkyo-ku, Tokyo, 113-8603, Japan
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Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
NOT_YET_RECRUITINGWarsaw, 04-628, Poland
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National Hospital Organization Mito Medical Center_Cardiovascular medicine
RECRUITINGIbaraki, 311-3193, Japan
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National Hospital Organization Yokohama Medical Center_Cardiology
RECRUITINGYokohama-shi, Kanagawa, 245-8575, Japan
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Nemocnice České Budějovice a.s.
RECRUITINGČeské Budějovice, 370 01, Czechia
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Osaka Metropolitan University Hospital_Cardiovascular Medicine
RECRUITINGOsaka-Shi, Osaka, 545-8586, Japan
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Pratia Prague, s.r.o
NOT_YET_RECRUITINGPrague, 130 00, Czechia
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Radboudumc
RECRUITINGNijmegen, 6525 GA, Netherlands
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Rhythm Heart Institute
RECRUITINGVadodara, Gujarat, 390022, India
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Royal Adelaide Hospital - Cardiology Department
RECRUITINGAdelaide, South Australia, 5000, Australia
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Royal Hobart Hospital
RECRUITINGHobart, Tasmania, 7000, Australia
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Sana Kliniken Berlin-Brandenburg GmbH - Lichtenberg
COMPLETEDBerlin, 10365, Germany
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Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology
RECRUITINGSapporo-shi, Hokkaido, 060-8543, Japan
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Seoul National University Bundang Hospital
COMPLETEDSeongnam-si, Gyeonggi-do, 13620, South Korea
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Seth GS Medical College & KEM Hospital
RECRUITINGMumbai, Maharashtra, 400012, India
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Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, 03722, South Korea
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Shri Mahant Indiresh Hospital
RECRUITINGDehradun, Uttarakhand, 248001, India
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Sir Ganga Ram Hospital-Cardiology
RECRUITINGNew Delhi, 110060, India
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Sir Ganga Ram Hospital-Cardiology
NOT_YET_RECRUITINGNew Delhi, 110060, India
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Southampton General Hospital
RECRUITINGSouthampton, SO16 6YD, United Kingdom
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St Bartholomew's Hospital - Cardiac Research Office
NOT_YET_RECRUITINGLondon, EC1A 7BE, United Kingdom
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St Bartholomew's Hospital - Cardiology
NOT_YET_RECRUITINGLondon, EC1A 7BE, United Kingdom
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Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
RECRUITINGKrakow, 31-826, Poland
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The James Cook University Hospital - Cardiology
RECRUITINGMiddlesbrough, TS4 3BW, United Kingdom
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The Prince Charles Hospital
NOT_YET_RECRUITINGBrisbane, Queensland, 4032, Australia
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The Royal Brompton Hospital - Respiratory CRF
NOT_YET_RECRUITINGLondon, SW3 6HP, United Kingdom
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The University of Osaka Hospital_Cardiovascular medicine
RECRUITINGOsaka, 565-0871, Japan
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Trialmed - Midlands
RECRUITINGBirmingham, B15 2SQ, United Kingdom
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Uniklinik Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. Intensivmedizin
RECRUITINGKiel, 24105, Germany
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Uniklinik TU Dresden - Herzzentrum Dresden GmbH
RECRUITINGDresden, 01307, Germany
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UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie
RECRUITINGHeidelberg, 69120, Germany
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Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie
NOT_YET_RECRUITINGEssen, 45147, Germany
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Universitätsklinikum Frankfurt aM - Kardiologie
RECRUITINGFrankfurt am Main, 60596, Germany
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Universitätsklinikum Halle - Innere Medizin III
RECRUITINGHalle, 06120, Germany
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Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
RECRUITINGWroclaw, 50-556, Poland
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Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
RECRUITINGLublin, 20-090, Poland
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Uniwersytecki Szpital Kliniczny w Bialymstoku
NOT_YET_RECRUITINGBialystok, Podlaskie Voivodeship, 15-276, Poland
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VMMC & Safdarjung Hospital
RECRUITINGNew Dehli, New Delhi, 110029, India
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Victorian Heart Hospital
RECRUITINGClayton, Victoria, 3168, Australia
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VieCuri - Cardiologie
RECRUITINGVenlo, 5912 BL, Netherlands
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Vseobecna fakultni nemocnice v Praze
RECRUITINGPrague, 128 08, Czechia
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Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
RECRUITINGPrzemyśl, 37-700, Poland
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Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
NOT_YET_RECRUITINGBiała Podlaska, 21-500, Poland
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Wonju Severance Christian Hospital
RECRUITINGGangwon-do, 26426, South Korea
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Wycombe General Hospital
RECRUITINGHigh Wycombe, HP11 2TT, United Kingdom
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Yokohama City University Medical Center_Cardiovascular Center
RECRUITINGKanagawa, 232-0024, Japan
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Yokohama City University Medical Center_Cardiovascular Center
NOT_YET_RECRUITINGKanagawa, 232-0024, Japan
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Zuyderland ziekenhuis - Cardiologie
RECRUITINGHeerlen, 6419 PC, Netherlands
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