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A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation
NCT06200207 · Novo Nordisk A/S
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Effects of Ziltivekimab Versus Placebo on Heart Failure Symptoms and Physical Function in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
About this study
The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.
Eligibility criteria
Inclusion Criteria:
* Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at screening (visit 1)
* Disease specific - cardiovascular:
* N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than or equal to 225 picograms per milliliter (pg/mL) (375 pg/mL for participants with atrial fibrillation/flutter) at screening
* Diagnosis of heart failure (New York heart association (NYHA) Class II-III)
* Left ventricular ejection fraction (LVEF) greater than 40 percent documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (example myocardial infarction (MI) or heart failure (HF) hospitalisation)
* Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following:
1. Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m\^2)
2. LA diameter greater than or equal to 3.8 centimeter (cm)
3. LA length greater than or equal to 5.0 cm
4. LA area greater than or equal to 20 square centimeter (cm\^2)
5. LA volume greater than or equal to 55 milliliter (mL)
6. Intraventricular septal thickness greater than or equal to 1.1 cm
7. Posterior wall thickness greater than or equal to 1.1 cm
8. LV mass index greater than or equal to 115 gram per square meter (g/m\^2) in men or greater than or equal to 95 g/m\^2 in women
h) E/e' (mean septal and lateral) greater than or equal to 10 i) e' (mean septal and lateral) less than 9 centimeter per second (cm/s)
* No heart failure hospitalisations or urgent heart failure visits between screening and randomisation
* Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 metres
* Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score lesser than 80 at screening
Exclusion Criteria:
* Medical conditions - cardiovascular:
* Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1)
* Systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving greater than or equal to 3 antihypertensive drugs
* Heart rate above 110 or below 40 beats per minute as evaluated on the Electrocardiogram (ECG) performed at screening (visit 1)
* Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1)
* Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1)
* Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2)
* Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease
* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease (COPD)
* Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism)
* Medical conditions - infections/immunosuppression:
* Clinical evidence of, or suspicion of, active infection at the discretion of the investigator
Study design
Enrollment target: 680 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-04-01
Estimated completion: 2027-01-08
Last updated: 2026-04-07
Interventions
Drug: ZiltivekimabDrug: Placebo
Primary outcomes
- • Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS) (From randomisation (month 0) to end-of-treatment (month 12))
Sponsor
Novo Nordisk A/S · industry
Contacts & investigators
ContactNovo Nordisk · contact · clinicaltrials@novonordisk.com · (+1) 866-867-7178
InvestigatorClinical Transparency dept. 2834 · study_director, Novo Nordisk A/S
All locations (240)
Advanced Cardiovascular, LLCCompleted
Alexander City, Alabama, United States
Eastern Shore Rsrch Inst, LLCActive Not Recruiting
Fairhope, Alabama, United States
Cardiology & Medicine ClinicCompleted
Little Rock, Arkansas, United States
Valley Clinical Trials, Inc.Active Not Recruiting
Northridge, California, United States
Valley Clinical Trials, Inc.Recruiting
Northridge, California, United States
UCI HealthCompleted
Orange, California, United States
South California Heart SpcActive Not Recruiting
Pasadena, California, United States
Clearwater Cardiovascular ConsultantsCompleted
Largo, Florida, United States
Clearwater Cardiovascular ConsultantsRecruiting
Largo, Florida, United States
Ocala Cardiovascular ResearchActive Not Recruiting
Ocala, Florida, United States
Ormond Beach Clinical ResearchActive Not Recruiting
Ormond Beach, Florida, United States
St Johns Ctr Clin Rsch-St. AugActive Not Recruiting
Saint Augustine, Florida, United States
GA Arrhythmia Cons & Rsch InstActive Not Recruiting
Macon, Georgia, United States
Velocity Clin Rsrch - SavannahCompleted
Savannah, Georgia, United States
Chicago Medical Research LLCCompleted
Hazel Crest, Illinois, United States
UofL Health Care OutpatientActive Not Recruiting
Louisville, Kentucky, United States
Maryland Cardiovascular Specialists - BaltimoreCompleted
Baltimore, Maryland, United States
MD Medical ResearchCompleted
Oxon Hill, Maryland, United States
Cardio and Vascular Assoc-CAVAActive Not Recruiting
Bloomfield Hills, Michigan, United States
Millennium CardiologyActive Not Recruiting
Farmington Hills, Michigan, United States
Kansas City VA Medical CenterCompleted
Kansas City, Missouri, United States
Kansas City VA Medical CenterRecruiting
Kansas City, Missouri, United States
Washington UniversityActive Not Recruiting
St Louis, Missouri, United States
Renown Regional Medical CenterActive Not Recruiting
Reno, Nevada, United States
Long Island Cardiovascular Consultants PCCompleted
Lake Success, New York, United States
Mount Sinai Hosp at NYCActive Not Recruiting
New York, New York, United States
Northwell Health Phys CardioActive Not Recruiting
Riverhead, New York, United States
University Of North Carolina At Chapel HillActive Not Recruiting
Chapel Hill, North Carolina, United States
AMS CardiologyActive Not Recruiting
Horsham, Pennsylvania, United States
Univ of Pennsylvania HospitalActive Not Recruiting
Philadelphia, Pennsylvania, United States
PharmaTex ResearchActive Not Recruiting
Amarillo, Texas, United States
PharmaTex ResearchRecruiting
Amarillo, Texas, United States
University of Texas Southwestern Medical CenterActive Not Recruiting
Dallas, Texas, United States
David Turbay, MD, PLLCActive Not Recruiting
El Paso, Texas, United States
Private Practice Leadership LLC.Completed
Katy, Texas, United States
Clinical Advancement CenterActive Not Recruiting
San Antonio, Texas, United States
Clinical Advancement Ctr, PLLCNot Yet Recruiting
San Antonio, Texas, United States
Sherman Clinical ResearchActive Not Recruiting
Sherman, Texas, United States
Northwest Heart CenterActive Not Recruiting
Tomball, Texas, United States
Sentara Health Research CenterCompleted
Norfolk, Virginia, United States
Virginia Commonwealth UniversityCompleted
Richmond, Virginia, United States
Cardiología PalermoActive Not Recruiting
City of Buenos Aires, Buenos Aires, Argentina
Centro Médico CIMELRecruiting
Lanús Este, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes SRLActive Not Recruiting
Buenos Aires, Argentina
CIPREC PueyrredonRecruiting
Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica ApliActive Not Recruiting
Buenos Aires, Argentina
CIPREC ArenalesCompleted
CABA, Argentina
Sanatorio EsperanzaActive Not Recruiting
Esperanza, Santa Fe, Argentina
Consultorio Integral de Atención al DiabéticoActive Not Recruiting
Morón, Argentina
Centro Cardiovascular SaltaRecruiting
Salta, Argentina
Investigaciones Clinicas TucumanActive Not Recruiting
San Miguel de Tucumán, Tucumán., Argentina
Canberra HospitalActive Not Recruiting
Garran, Australian Capital Territory, Australia
John Hunter Hospital - Cardiovascular DepartmentActive Not Recruiting
New Lambton Heights, New South Wales, Australia
John Hunter HospitalRecruiting
New Lambton Heights, New South Wales, Australia
Illawarra Heart Health CentreActive Not Recruiting
Wollongong, New South Wales, Australia
The Prince Charles HospitalActive Not Recruiting
Brisbane, Queensland, Australia
The Prince Charles HospitalRecruiting
Brisbane, Queensland, Australia
Ballarat Base HospitalActive Not Recruiting
Ballarat, Victoria, Australia
Ballarat Base HospitalNot Yet Recruiting
Ballarat, Victoria, Australia
The Cardiologists Pty LtdActive Not Recruiting
Epping, Victoria, Australia
The Cardiologists Pty LtdNot Yet Recruiting
Epping, Victoria, Australia
Advara HeartCare MulgraveActive Not Recruiting
Mulgrave, Victoria, Australia
Advara HeartCareActive Not Recruiting
Mulgrave, Victoria, Australia
Fiona Stanley Hospital CardiologyNot Yet Recruiting
Murdoch, Western Australia, Australia
MHAT Puls AD, Cardiology DepartmentCompleted
Blagoevgrad, Bulgaria
MHAT Haskovo ADCompleted
Haskovo, Bulgaria
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Pleven, Bulgaria
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of CardiologyActive Not Recruiting
Plovdiv, Bulgaria
MC Hera EOOD - SofiaActive Not Recruiting
Sofia, Bulgaria
Medical center ISUL - Tsaritsa Yoanna EOODActive Not Recruiting
Sofia, Bulgaria
UMHATEM N.I. Pirogov EADActive Not Recruiting
Sofia, Bulgaria
UMHAT Sveta Anna Sofia AD, Clinic of CardiologyCompleted
Sofia, Bulgaria
Medical Center Synexus Sofia EOODCompleted
Sofia, Bulgaria
University of Calgary_CalgaryActive Not Recruiting
Calgary, Alberta, Canada
Cambridge Cardiac Care CentreActive Not Recruiting
Cambridge, Ontario, Canada
Saul Vizel Pro. Med. CorpCompleted
Cambridge, Ontario, Canada
Corcare Cardiovascular ResearchCompleted
Scarborough Village, Ontario, Canada
Diabetes Heart Research CentreActive Not Recruiting
Toronto, Ontario, Canada
Diabetes Heart Research CentreRecruiting
Toronto, Ontario, Canada
CPS ResearchActive Not Recruiting
Waterloo, Ontario, Canada
CPS ResearchRecruiting
Waterloo, Ontario, Canada
Clinical Research Solutions Inc.Active Not Recruiting
Waterloo, Ontario, Canada
Institut de Cardiologie de MontrealActive Not Recruiting
Montreal, Quebec, Canada
Montreal General HospitalActive Not Recruiting
Montreal, Quebec, Canada
CHU de Quebec-Uni Laval-HotelActive Not Recruiting
Québec, Canada
Innera s.r.o.Active Not Recruiting
Benešov, Czechia
Kardiologicka ambulance Brno s.r.o.Active Not Recruiting
Brno, Czechia
Vojenská nemocnice Brno p.o.Active Not Recruiting
Brno, Czechia
Ordinace pro choroby srdceCompleted
Chomutov, Czechia
MEDICON a.s.Active Not Recruiting
Prague, Czechia
Svitavska nemocnice KardiologieCompleted
Svitavy, Czechia
Kardiologická ambulance MUDr. Ferkl s.r.o.Completed
Trutnov, Czechia
Nemocnice AGEL Třinec-Podlesí a.s.Active Not Recruiting
Třinec, Czechia
Centre Hospitalier Regional Universitaire de Tours-Hopital TrousseauActive Not Recruiting
Chambray-lès-Tours, France
Centre Hospitalier Universitaire de PoitiersCompleted
Poitiers, France
Centre Hospitalier Universitaire de Rennes - Hopital PontchaillouCompleted
Rennes, France
Centre Hospitalier Universitaire de Rouen-Hopital Charles NicolleCompleted
Rouen, France
Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte MusseActive Not Recruiting
Toulon, France
Polyclinique VaubanCompleted
Valenciennes, France
Chru de Nancy - Hopital BraboisActive Not Recruiting
Vandœuvre-lès-Nancy, France
Kardiologisch-Angiologische Praxis Herzzentrum BremenCompleted
Bremen, Germany
Uniklinik TU Dresden - Herzzentrum Dresden GmbHActive Not Recruiting
Dresden, Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbHActive Not Recruiting
Elsterwerda, Germany
Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. IICompleted
Erfurt, Germany
MVZ CCB Frankfurt und Main-Taunus GbRCompleted
Frankfurt, Germany
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Freiburg im Breisgau, Germany
MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische StudienActive Not Recruiting
Fulda, Germany
Universität des Saarlandes - Innere Med. IIIActive Not Recruiting
Homburg, Germany
Kardiopraxis SchirmerCompleted
Kaiserslautern, Germany
Gesundheitscentrum Mainz (Regner / Schmitt)Completed
Mainz, Germany
Alexandra General Hospital, Therapeutic ClinicActive Not Recruiting
Athens, Attica, Greece
Evangelismos HospitalActive Not Recruiting
Athens, Greece
Naval Hospital of Athens - Clinic of CardiologyActive Not Recruiting
Athens, Greece
"Laiko" General Hospital of AthensActive Not Recruiting
Athens, Greece
'G. Gennimatas' General Hospital of Athens - Cardiology DepartmentActive Not Recruiting
Athens, Greece
'G. Gennimatas' General Hospital of AthensNot Yet Recruiting
Athens, Greece
Konstantopouleio G.H. of Athens, "Agia Olga"Active Not Recruiting
Athens, Greece
"Hygeia" General Hospital of AthensActive Not Recruiting
Athens, Greece
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology ClinicActive Not Recruiting
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Naval Hospital of AthensNot Yet Recruiting
Athens, Greece
U.G.H of Athens "Attikon"Active Not Recruiting
Chaidari, Athens, Greece
U.G.H of Athens "Attikon"Not Yet Recruiting
Chaidari, Athens, Greece
General Hospital of Kalamata - Cardiology DepartmentCompleted
Chalcis, Greece
General Hospital of Chios "Skilitsio" - Cardiology ClinicActive Not Recruiting
Chios, Greece
Univ Gen Hospital Larisa, Cardiology Medicine ClinicActive Not Recruiting
Larissa, Greece
Sismanogleio General Hospital - Cardiology DepartmentActive Not Recruiting
Marousi, Greece
"AHEPA" University General Hospital of ThessalonikiActive Not Recruiting
Thessaloniki, Greece
'Ippokrateio' General Hospital of ThessalonikiCompleted
Thessaloniki, Greece
Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology DptCompleted
Thessaloniki, Greece
Government Siddhartha Medical College & Government General Hospital, VijayawadaActive Not Recruiting
Vijayawada, Andhra Pradesh, India
King George HospitalCompleted
Visakhapatnam, Andhra Pradesh, India
Rhythm Heart InstituteActive Not Recruiting
Vadodara, Gujarat, India
KLE's Dr. Prabhakar Kore Hospital & Medical Research CentreNot Yet Recruiting
Belagavi, Karnataka, India
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Belagavi, Karnataka, India
St John's Medical College HospitalCompleted
Bengaluru, Karnataka, India
St John's Medical College HospitalRecruiting
Bengaluru, Karnataka, India
Sri Jayadeva Institute of Cardiovascular Sciences & ResearchCompleted
Bengaluru, Karnataka, India
Sri Jayadeva Institute of Cardiovascular Sciences & ResearchNot Yet Recruiting
Bengaluru, Karnataka, India
Manipal Hospital, MysuruCompleted
Mysuru, Karnataka, India
Kasturba Medical College and Hospital, ManipalNot Yet Recruiting
Udupi, Karnataka, India
Kasturba Medical College and Hospital, ManipalCompleted
Udupi, Karnataka, India
Sengupta Hospital and Research InstituteActive Not Recruiting
Nagpur, Maharashtra, India
Sengupta Hospital and Research InstituteRecruiting
Nagpur, Maharashtra, India
All India Institute of Medical Sciences (AIIMS), NagpurActive Not Recruiting
Nagpur, Maharashtra, India
Chopda Medicare and Research Centre Pvt. Ltd.Completed
Nashik, Maharashtra, India
Chopda Medicare and Research Centre Pvt. Ltd.Not Yet Recruiting
Nashik, Maharashtra, India
Vijan Hospital & Research CentreActive Not Recruiting
Nashik, Maharashtra, India
Vijan Hospital & Research CentreNot Yet Recruiting
Nashik, Maharashtra, India
Villoo Poonawalla Memorial HospitalActive Not Recruiting
Pune, Maharashtra, India
G B Pant Institute of Postgraduate Medical Education and ResearchActive Not Recruiting
New Delhi, National Capital Territory of Delhi, India
G B Pant Institute of Postgraduate Medical Education and ResearchNot Yet Recruiting
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences (AIIMS)Completed
New Delhi, National Capital Territory of Delhi, India
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New Delhi, National Capital Territory of Delhi, India
Sir Ganga Ram HospitalActive Not Recruiting
New Delhi, National Capital Territory of Delhi, India
Rajiv Gandhi Super Speciality HospitalCompleted
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences (AIIMS), BhubaneswarActive Not Recruiting
Bhubaneswar, Odisha, India
All India Institute of Medical Sciences (AIIMS), BhubaneswarRecruiting
Bhubaneswar, Odisha, India
S.P. Medical College & Associated Group of HospitalsCompleted
Bikaner, Rajasthan, India
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)Completed
Puducherry, Tamil Nadu, India
Guru Nanak CARE HospitalsActive Not Recruiting
Hyderabad, Telangana, India
Malla Reddy Narayana Multispeciality HospitalActive Not Recruiting
Hyderabad, Telangana, India
Jawaharlal Nehru Medical College and HospitalActive Not Recruiting
Aligarh, Uttar Pradesh, India
Ganesh Shankar Vidyarthe Memorial (GSVM) Medical CollegeActive Not Recruiting
Kanpur, Uttar Pradesh, India
Ganesh Shankar Vidyarthe Memorial (GSVM) Medical CollegeNot Yet Recruiting
Kanpur, Uttar Pradesh, India
Dr. Ram Manohar Lohia Institute of Medical SciencesCompleted
Lucknow, Uttar Pradesh, India
Sanjay Gandhi Postgraduate Institute of Medical SciencesActive Not Recruiting
Lucknow, Uttar Pradesh, India
Jawaharlal Nehru Medical College and HospitalNot Yet Recruiting
Aligarh, Utter Pradesh, India
B M Birla Heart Research CentreCompleted
Kolkata, West Bengal, India
B M Birla Heart Research CentreNot Yet Recruiting
Kolkata, West Bengal, India
Hospital Sultanah AminahActive Not Recruiting
Johor Bahru, Johor, Malaysia
Hospital Sultanah AminahRecruiting
Johor Bahru, Johor, Malaysia
Hospital Sultanah BahiyahActive Not Recruiting
Alor Star, Kedah, Malaysia
Hospital Raja Perempuan Zainab IIActive Not Recruiting
Kota Bharu, Kelantan, Malaysia
University Malaya Medical CentreRecruiting
Kuala Lumpur, Kuala Lumpur, Malaysia
University Malaya Medical CentreActive Not Recruiting
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Tengku Ampuan AfzanActive Not Recruiting
Kuantan, Pahang, Malaysia
Hospital Raja Permaisuri Bainun IpohCompleted
Ipoh, Perak, Malaysia
Hospital SerdangActive Not Recruiting
Kajang, Selangor, Malaysia
Hospital Raja Perempuan Zainab IIRecruiting
Kota Bharu, Kelantan, Malaysia
Centrum Medyczne Intercor Sp. z o.o.Active Not Recruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Kardio Life - Tomasz BorkowskiActive Not Recruiting
Włocławek, Kuyavian-Pomeranian Voivodeship, Poland
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Krakow, Lesser Poland Voivodeship, Poland
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Oświęcim, Lesser Poland Voivodeship, Poland
Pratia S.A.Completed
Jelenia Góra, Lower Silesian Voivodeship, Poland
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Gdynia, Pomeranian Voivodeship, Poland
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Bielsko-Biala, Poland
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Piotrkow Trybunalski, Poland
Uniwersytecki Szpital Kliniczny W PoznaniuCompleted
Poznan, Poland
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American Heart of Poland S.A.Completed
Tychy, Poland
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Lodz, Łódź Voivodeship, Poland
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CHLO, EPE - Hospital São Francisco XavierNot Yet Recruiting
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Hospital Ramón y CajalActive Not Recruiting
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Sanlúcar de Barrameda, Spain
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Santiago de Compostela, Spain
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Eskişehir Osmangazi Üniversitesi Hastanesi- KardiyolojiActive Not Recruiting
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Raigmore HospitalCompleted
Inverness, Highland, United Kingdom
St. Richard's Hospital_CardiologyActive Not Recruiting
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FutureMedsActive Not Recruiting
Birmingham, United Kingdom
Ninewells HospitalCompleted
Dundee, United Kingdom
Peterborough City HospitalCompleted
Peterborough, United Kingdom