Uno studio di ricerca che esamina il funzionamento di Ziltivekimab rispetto al placebo nei partecipanti con insufficienza cardiaca e infiammazione (ATHENA)
Effetti di Ziltivekimab rispetto al placebo sui sintomi dell'insufficienza cardiaca e sulla funzione fisica in pazienti con insufficienza cardiaca con frazione di eiezione leggermente ridotta o preservata e infiammazione sistemica
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Buenos Aires, Argentina, C1425AGC
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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Buenos Aires, Argentina, B1878GEG
- Instituto de Investigaciones Clinicas Quilmes SRL
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Buenos Aires, Argentina, C1119ACN
- CIPREC Pueyrredon
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CABA, Argentina, C1061AAS
- CIPREC Arenales
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Esperanza, Santa Fe, Argentina, S3080BQV
- Sanatorio Esperanza
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Morón, Argentina, B1708IFF
- Consultorio Integral de Atención al Diabético
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Salta, Argentina, 4400
- Centro Cardiovascular Salta
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San Miguel de Tucumán, Tucumán., Argentina, T4000
- Investigaciones Clinicas Tucuman
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Buenos Aires
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City of Buenos Aires, Buenos Aires, Argentina, C1425
- Cardiología Palermo
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Lanús Este, Buenos Aires, Argentina, B1824KAJ
- Centro Médico CIMEL
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Australian Capital Territory
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Garran, Australian Capital Territory, Australia, 2605
- Canberra Hospital
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New South Wales
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New Lambton Heights, New South Wales, Australia, 2305
- John Hunter Hospital
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New Lambton Heights, New South Wales, Australia, 2305
- John Hunter Hospital - Cardiovascular Department
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Wollongong, New South Wales, Australia, 2500
- Illawarra Heart Health Centre
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Queensland
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Brisbane, Queensland, Australia, 4032
- The Prince Charles Hospital
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Chermside, Queensland, Australia, 4032
- The Prince Charles Hospital - Cardiology Clinical Research Centre
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Victoria
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Ballarat, Victoria, Australia, 3350
- Ballarat Base Hospital
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Epping, Victoria, Australia, 3076
- The Cardiologists Pty Ltd
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Epping, Victoria, Australia, 3076
- Northern Private Hospital Epping - The Cardiologists
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Mulgrave, Victoria, Australia, 3170
- Advara HeartCare Mulgrave
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Mulgrave, Victoria, Australia, 3170
- Advara HeartCare
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Fiona Stanley Hospital Cardiology
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Blagoevgrad, Bulgaria, 2700
- MHAT Puls AD, Cardiology Department
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Haskovo, Bulgaria, 6300
- MHAT Haskovo AD
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Pleven, Bulgaria, 5804
- MHAT Heart and Brain EAD - Pleven, Cardiology
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Plovdiv, Bulgaria, 4002
- UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology
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Sofia, Bulgaria, 1784
- Medical Center Synexus Sofia EOOD
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Sofia, Bulgaria, 1527
- Medical center ISUL - Tsaritsa Yoanna EOOD
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Sofia, Bulgaria, 1510
- MC Hera EOOD - Sofia
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Sofia, Bulgaria, 1750
- MHAT Sveta Anna Sofia AD, Clinic of Cardiology
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Sofia, Bulgaria, 1606
- UMHATEM N.I. Pirogov EAD
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Québec, Canada, G1R 2J6
- CHU de Quebec-Uni Laval-Hotel
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- University of Calgary_Calgary
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Ontario
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Cambridge, Ontario, Canada, N1R 6V6
- Cambridge Cardiac Care Centre
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Cambridge, Ontario, Canada, N1R 7R1
- Saul Vizel Pro. Med. Corp
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Scarborough Village, Ontario, Canada, M1B 5N1
- Corcare Cardiovascular Research
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Toronto, Ontario, Canada, M6G 1M2
- Diabetes Heart Research Centre
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Waterloo, Ontario, Canada, N2T 0C1
- CPS Research
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Waterloo, Ontario, Canada, N2T OC1
- Clinical Research Solutions Inc.
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Quebec
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Montreal, Quebec, Canada, H1T 1C8
- Institut de Cardiologie de Montreal
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Montreal, Quebec, Canada, H3G 1A4
- Montreal General Hospital
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Benešov, Cechia, 256 01
- Innera s.r.o.
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Brno, Cechia, 612 00
- Kardiologicka ambulance Brno s.r.o.
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Brno, Cechia, 61500
- Vojenská nemocnice Brno p.o.
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Chomutov, Cechia, 430 02
- Ordinace pro choroby srdce
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Prague, Cechia, 170 00
- MEDICON a.s.
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Svitavy, Cechia, 568 25
- Svitavska nemocnice Kardiologie
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Trutnov, Cechia, 541 01
- Kardiologická ambulance MUDr. Ferkl s.r.o.
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Třinec, Cechia, 739 61
- Nemocnice AGEL Třinec-Podlesí a.s.
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Chambray-lès-Tours, Francia, 37170
- Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau
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Poitiers, Francia, 86000
- Centre Hospitalier Universitaire de Poitiers
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Rennes, Francia, 35000
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Rouen, Francia, 76031
- Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
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Toulon, Francia, 83100
- Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse
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Valenciennes, Francia, 59300
- Polyclinique Vauban
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Vandœuvre-lès-Nancy, Francia, 54500
- Chru de Nancy - Hopital Brabois
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Bremen, Germania, 28277
- Kardiologisch-Angiologische Praxis Herzzentrum Bremen
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Dresden, Germania, 01307
- Uniklinik TU Dresden - Herzzentrum Dresden GmbH
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Elsterwerda, Germania, 04910
- Zentrum für klinische Studien Südbrandenburg GmbH
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Erfurt, Germania, 99097
- Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II
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Frankfurt, Germania, 60389
- MVZ CCB Frankfurt und Main-Taunus GbR
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Freiburg im Breisgau, Germania, 79106
- Universitätsklinikum Freiburg - Medical Center
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Fulda, Germania, 36037
- MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
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Homburg, Germania, 66421
- Universität des Saarlandes - Innere Med. III
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Kaiserslautern, Germania, 67655
- Kardiopraxis Schirmer
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Mainz, Germania, 55116
- Gesundheitscentrum Mainz (Regner / Schmitt)
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Athens, Grecia, 11527
- "Laiko" General Hospital of Athens
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Athens, Grecia, 10676
- Evangelismos Hospital
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Athens, Grecia, GR-11521
- Naval Hospital of Athens
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Athens, Grecia, 11527
- 'G. Gennimatas' General Hospital of Athens
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Athens, Grecia, 14233
- Konstantopouleio G.H. of Athens, "Agia Olga"
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Athens, Grecia, 15123
- "Hygeia" General Hospital of Athens
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Athens, Grecia, 11527
- 'G. Gennimatas' General Hospital of Athens - Cardiology Department
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Athens, Grecia, 15562
- Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology Clinic
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Athens, Grecia, 11521
- Naval Hospital of Athens - Clinic of Cardiology
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Chaidari, Athens, Grecia, GR-12462
- U.G.H of Athens "Attikon"
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Chaidari, Athens, Grecia, 12462
- U.G.H of Athens "Attikon"
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Chalcis, Grecia, 34100
- General Hospital of Kalamata - Cardiology Department
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Chios, Grecia, 82100
- General Hospital of Chios "Skilitsio" - Cardiology Clinic
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Larissa, Grecia, 41110
- Univ Gen Hospital Larisa, Cardiology Medicine Clinic
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Marousi, Grecia, 151 26
- Sismanogleio General Hospital - Cardiology Department
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Thessaloniki, Grecia, 54636
- "AHEPA" University General Hospital of Thessaloniki
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Thessaloniki, Grecia, 54642
- 'Ippokrateio' General Hospital of Thessaloniki
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Thessaloniki, Grecia, 57010
- Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt
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Attica
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Athens, Attica, Grecia, 11528
- Alexandra General Hospital, Therapeutic Clinic
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Andhra Pradesh
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Vijayawada, Andhra Pradesh, India, 520008
- Government Siddhartha Medical College & Government General Hospital, Vijayawada
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Visakhapatnam, Andhra Pradesh, India, 530002
- King George Hospital
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Gujarat
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Vadodara, Gujarat, India, 390022
- Rhythm Heart Institute
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Karnataka
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Belagavi, Karnataka, India, 590010
- KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
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Belagavi, Karnataka, India, 590010
- KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
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Bengaluru, Karnataka, India, 560034
- St John's Medical College Hospital
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Bengaluru, Karnataka, India, 560069
- Sri Jayadeva Institute of Cardiovascular Sciences & Research
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Mysuru, Karnataka, India, 570015
- Manipal Hospital, Mysuru
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Udupi, Karnataka, India, 576104
- Kasturba Medical College and Hospital, Manipal
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Maharashtra
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Nagpur, Maharashtra, India, 441108
- All India Institute of Medical Sciences (AIIMS), Nagpur
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Nagpur, Maharashtra, India, 440033
- Sengupta Hospital and Research Institute
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Nashik, Maharashtra, India, 422005
- Vijan Hospital & Research Centre
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Nashik, Maharashtra, India, 422005
- Chopda Medicare and Research Centre Pvt. Ltd.
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Pune, Maharashtra, India, 411028
- Villoo Poonawalla Memorial Hospital
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110029
- All India Institute of Medical Sciences (AIIMS)
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New Delhi, National Capital Territory of Delhi, India, 110060
- Sir Ganga Ram Hospital
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New Delhi, National Capital Territory of Delhi, India, 110002
- G B Pant Institute of Postgraduate Medical Education and Research
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New Delhi, National Capital Territory of Delhi, India, 110029
- Vardhaman Mahavir Medical College & Safdarjung Hospital
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New Delhi, National Capital Territory of Delhi, India, 110093
- Rajiv Gandhi Super Speciality Hospital
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Odisha
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Bhubaneswar, Odisha, India, 751019
- All India Institute of Medical Sciences (AIIMS), Bhubaneswar
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Rajasthan
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Bikaner, Rajasthan, India, 334003
- S.P. Medical College & Associated Group of Hospitals
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Tamil Nadu
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Puducherry, Tamil Nadu, India, 605006
- Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
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Telangana
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Hyderabad, Telangana, India, 500020
- Guru Nanak CARE Hospitals
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Hyderabad, Telangana, India, 500055
- Malla Reddy Narayana Multispeciality Hospital
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Uttar Pradesh
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Aligarh, Uttar Pradesh, India, 202002
- Jawaharlal Nehru Medical College and Hospital
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Kanpur, Uttar Pradesh, India, 208002
- Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College
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Lucknow, Uttar Pradesh, India, 226014
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
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Lucknow, Uttar Pradesh, India, 226010
- Dr. Ram Manohar Lohia Institute of Medical Sciences
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Utter Pradesh
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Aligarh, Utter Pradesh, India, 202002
- Jawaharlal Nehru Medical College and Hospital
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West Bengal
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Kolkata, West Bengal, India, 700027
- B M Birla Heart Research Centre
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Kota Bharu, Kelantan, Malaysia, 15586
- Hospital Raja Perempuan Zainab II
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Johor
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Johor Bahru, Johor, Malaysia, 80100
- Hospital Sultanah Aminah
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Kedah
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Alor Star, Kedah, Malaysia, 05460
- Hospital Sultanah Bahiyah
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Kelantan
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Kota Bharu, Kelantan, Malaysia, 15586
- Hospital Raja Perempuan Zainab II
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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Lembah Pantai, Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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Pahang
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Kuantan, Pahang, Malaysia, 25100
- Hospital Tengku Ampuan Afzan
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Perak
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Ipoh, Perak, Malaysia, 30450
- Hospital Raja Permaisuri Bainun Ipoh
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Selangor
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Kajang, Selangor, Malaysia, 43000
- Hospital Serdang
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Bielsko-Biala, Polonia, 43-316
- American Heart of Poland S.A.
-
Bydgoszcz, Polonia, 85-681
- 10 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bydgoszczy
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Gdynia, Polonia, 81-348
- Szpitale Pomorskie Sp. z o.o.
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Lublin, Polonia, 20-601
- Zanamed Medical Clinic Sp. z o.o.
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Piotrkow Trybunalski, Polonia, 97-300
- Trialmed Sp. z o. o.
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Poznan, Polonia, 61-848
- Uniwersytecki Szpital Kliniczny W Poznaniu
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Tychy, Polonia, 43-100
- American Heart of Poland S.A.
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Warsaw, Polonia, 02-507
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polonia, 85-605
- Centrum Medyczne Intercor Sp. z o.o.
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Włocławek, Kuyavian-Pomeranian Voivodeship, Polonia, 87-800
- Kardio Life
-
Włocławek, Kuyavian-Pomeranian Voivodeship, Polonia, 87-800
- Kardio Life - Tomasz Borkowski
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polonia, 30-721
- Linden sp. z o.o. sp. k.
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Krakow, Lesser Poland Voivodeship, Polonia, 30-002
- Cardiomedicum Sp. z o.o.
-
Oświęcim, Lesser Poland Voivodeship, Polonia, 32-600
- Formed 2 Sp. z o.o.
-
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Lower Silesian Voivodeship
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Jelenia Góra, Lower Silesian Voivodeship, Polonia, 58-506
- Pratia S.A.
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Wroclaw, Lower Silesian Voivodeship, Polonia, 50-981
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
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Lublin Voivodeship
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Puławy, Lublin Voivodeship, Polonia, 24-100
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
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Masovian Voivodeship
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Żyrardów, Masovian Voivodeship, Polonia, 96-300
- Prywatna Praktyka Lekarska Anna Chudoba
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polonia, 15-540
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Pomeranian Voivodeship
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Gdynia, Pomeranian Voivodeship, Polonia, 81-157
- Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
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Gdynia, Pomeranian Voivodeship, Polonia, 81-348
- Szpitale Pomorskie Sp. z o.o.
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Polonia, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
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Lodz, Łódź Voivodeship, Polonia, 90-549
- Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi
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Guilhufe - Penafiel, Portogallo, 4560-136
- CHTâmega e Sousa - Hospital Padre Américo
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Lisbon, Portogallo, 1500-650
- Hospital da Luz
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Lisbon, Portogallo, 1649-035
- Centro Hospitalar Lisboa Norte
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Lisbon, Portogallo, 1449-005
- CHLO, EPE - Hospital São Francisco Xavier
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Setúbal, Portogallo, 2910-446
- Centro Hospitalar de Setubal
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-
-
-
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Birmingham, Regno Unito, B21 9RY
- FutureMeds
-
Dundee, Regno Unito, DD2 1GZ
- Ninewells Hospital
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Peterborough, Regno Unito, PE3 9GZ
- Peterborough City Hospital
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Highland
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Inverness, Highland, Regno Unito, IV2 3JH
- Raigmore Hospital
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West Sussex
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Chichester, West Sussex, Regno Unito, PO19 6SE
- St. Richard's Hospital_Cardiology
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-
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-
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Madrid, Spagna, 28007
- Hospital Gregorio Marañón
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Madrid, Spagna, 28034
- Hospital Ramón y Cajal
-
Sanlúcar de Barrameda, Spagna, 11540
- H Virgen del Camino_Sanlúcar_Medicina Interna
-
Santiago de Compostela, Spagna, 15706
- Complejo Hospitalario Universitario de Santiago
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Seville, Spagna, 41003
- Clínica Nuevas Tecnologías en Diabetes y Endocrinología
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Valencia, Spagna, 46010
- Fundación para la Investigación del Hospital Clínico de Valencia (INCLIVA)
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Andalusia
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Castilleja de la Cuesta, Andalusia, Spagna, 41950
- Hospital Vithas Sevilla
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Castille and León
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Salamanca, Castille and León, Spagna, 37007
- Hospital Universitario de Salamanca
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Madrid
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Majadahonda, Madrid, Spagna, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Alabama
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Alexander City, Alabama, Stati Uniti, 35010
- Advanced Cardiovascular, LLC
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Fairhope, Alabama, Stati Uniti, 36532
- Eastern Shore Rsrch Inst, LLC
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72204
- Cardiology & Medicine Clinic
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California
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Northridge, California, Stati Uniti, 91325
- Valley Clinical Trials, Inc.
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Orange, California, Stati Uniti, 92868
- UCI Health
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Pasadena, California, Stati Uniti, 91105
- South California Heart Spc
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Florida
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Largo, Florida, Stati Uniti, 33777
- Clearwater Cardiovascular Consultants
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Ocala, Florida, Stati Uniti, 34471
- Ocala Cardiovascular Research
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Ormond Beach, Florida, Stati Uniti, 32174
- Ormond Beach Clinical Research
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Saint Augustine, Florida, Stati Uniti, 32086
- St Johns Ctr Clin Rsch-St. Aug
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Georgia
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Macon, Georgia, Stati Uniti, 31201
- GA Arrhythmia Cons & Rsch Inst
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Savannah, Georgia, Stati Uniti, 31406
- Velocity Clin Rsrch - Savannah
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Illinois
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Hazel Crest, Illinois, Stati Uniti, 60429
- Chicago Medical Research LLC
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40202
- UofL Health Care Outpatient
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Maryland
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Baltimore, Maryland, Stati Uniti, 21229
- Maryland Cardiovascular Specialists - Baltimore
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Oxon Hill, Maryland, Stati Uniti, 20745
- MD Medical Research
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Michigan
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Bloomfield Hills, Michigan, Stati Uniti, 48304
- Cardio and Vascular Assoc-CAVA
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Farmington Hills, Michigan, Stati Uniti, 48334
- Millennium Cardiology
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Missouri
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Kansas City, Missouri, Stati Uniti, 64128
- Kansas City VA Medical Center
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St Louis, Missouri, Stati Uniti, 63110
- Washington University
-
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Nevada
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Reno, Nevada, Stati Uniti, 89502
- Renown Regional Medical Center
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New York
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Lake Success, New York, Stati Uniti, 11042
- Long Island Cardiovascular Consultants PC
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New York, New York, Stati Uniti, 10019
- Mount Sinai Hosp at NYC
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Riverhead, New York, Stati Uniti, 11901
- Northwell Health Phys Cardio
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599-7046
- University Of North Carolina At Chapel Hill
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Pennsylvania
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Horsham, Pennsylvania, Stati Uniti, 19044
- AMS Cardiology
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Univ of Pennsylvania Hospital
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Texas
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Amarillo, Texas, Stati Uniti, 79106
- PharmaTex Research
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Dallas, Texas, Stati Uniti, 75390-9302
- University of Texas Southwestern Medical Center
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El Paso, Texas, Stati Uniti, 79905
- David Turbay, MD, PLLC
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Katy, Texas, Stati Uniti, 77493
- Private Practice Leadership LLC.
-
San Antonio, Texas, Stati Uniti, 78212
- Clinical Advancement Center
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San Antonio, Texas, Stati Uniti, 78212
- Clinical Advancement Ctr, PLLC
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Sherman, Texas, Stati Uniti, 75090
- Sherman Clinical Research
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Tomball, Texas, Stati Uniti, 77375
- Northwest Heart Center
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Virginia
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Norfolk, Virginia, Stati Uniti, 23507
- Sentara Health Research Center
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Richmond, Virginia, Stati Uniti, 23219
- Virginia Commonwealth University
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-
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Adana, Turchia (Türkiye), 01000
- T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
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Adana, Turchia (Türkiye), 01060
- Adana Şehir Eğitim ve Araştırma Hastanesi
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Afyonkarahisar, Turchia (Türkiye), 03200
- Afyonkarahisar Health Sciences University
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Afyonkarahisar, Turchia (Türkiye), 03200
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji
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Ankara, Turchia (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Kardiyoloji
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Ankara, Turchia (Türkiye), 06800
- Ankara Sehir Hastanesi Cardiology
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Bursa, Turchia (Türkiye), 16110
- Bursa Şehir Hastanesi- Kardiyoloji
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Edirne, Turchia (Türkiye), 22030
- Trakya University
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Edirne, Turchia (Türkiye), 22030
- Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji
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Istanbul, Turchia (Türkiye), 34480
- Başakşehir Çam ve Sakura Şehir Hastanesi
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Kayseri, Turchia (Türkiye), 38039
- Erciyes University Cardiology
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Kayseri, Turchia (Türkiye), 38039
- Erciyes Üniversitesi Hastanesi- Kardiyoloji
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Kocaeli, Turchia (Türkiye), 41380
- Kocaeli Üniversitesi Hastanesi- Kardiyoloji
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Odunpazari
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Eskişehir, Odunpazari, Turchia (Türkiye), 26040
- Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
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Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at screening (visit 1)
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Disease specific - cardiovascular:
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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:
- Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m^2)
- LA diameter greater than or equal to 3.8 centimeters (cm)
- LA length greater than or equal to 5.0 cm
- LA area greater than or equal to 20 square centimeters (cm^2)
- LA volume greater than or equal to 55 milliliters (mL)
- Intraventricular septal thickness greater than or equal to 1.1 cm
- Posterior wall thickness greater than or equal to 1.1 cm
- LV mass index greater than or equal to 115 grams 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 centimeters 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Ziltivekimab
Participants will receive ziltivekimab administered subcutaneously (s.c.) once-monthly and added to standard of care for 12 months. |
Zilitivekimab will be administered subcutaneously once-monthly. |
|
Comparatore placebo: Placebo
Participants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months. |
Placebo matched to ziltivekimab will be administered subcutaneously once-monthly. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
Lasso di tempo: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as score (score on scale; range; 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. |
From randomisation (month 0) to end-of-treatment (month 12)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no)
Lasso di tempo: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Participant achieving threshold for clinically meaningful within-participant change in 6-minute walk distance (6MWD) (yes/no)
Lasso di tempo: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as count of participants. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Participants improving 5 points or more in KCCQ-CSS (yes/no)
Lasso di tempo: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Participants improving 10 points or more in KCCQ-CSS (yes/no)
Lasso di tempo: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Change in subscales of KCCQ (total symptom score, physical limitations score, social limitations score, and health-related quality of life)
Lasso di tempo: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as score (score on scale; range 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Change in six-minute walk distance (6MWD)
Lasso di tempo: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured in meters. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Change in high-sensitivity C-reactive protein (hs-CRP)
Lasso di tempo: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as ratio to baseline. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Participants experiencing improvement in New York heart association (NYHA) Class (yes/no)
Lasso di tempo: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as count of participants. The New York Heart Association (NYHA) classification provides a simple way of classifying the extent of heart failure (HF). It classifies patients in one of four categories based on their limitations during physical activity - Class I: Participant with cardiac disease but without resulting limitations of physical activity, Class II: Participants with cardiac disease resulting in slight limitation of physical activity, Class III: Participants with cardiac disease resulting in marked limitation of physical activity, Class IV: Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP)
Lasso di tempo: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as ratio to baseline. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Change in eGFR (CKD-EPI)
Lasso di tempo: From randomisation (month 0) to end-of-treatment (month 12)
|
eGFR (CKD-EPI) is estimated glomerular filtration rate chronic kidney disease - epidemiology collaboration. Measured in milliliter per minute per 1.73 square meter (ml/min/1.73^2). |
From randomisation (month 0) to end-of-treatment (month 12)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Clinical Transparency dept. 2834, Novo Nordisk A/S
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NN6018-4914
- U1111-1293-7516 (Altro identificatore: World Health Organisation (WHO))
- 2023-506988-34 (Altro identificatore: European Medical Agency (EMA))
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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