Clinical trial NCT03683186: A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
Official title: A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: PAH
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Hypertension
Connective Tissue Diseases
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Disease
Keywords: Prostacyclin
Connective Tissue Disease-Associated
6 Minute Walk Test
6 Minute Walk Distance
Pulmonary Vascular Resistance
Right Ventricular Function
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-09-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

Detailed description: Study ROR-PH-303 is a multicenter, open-label extension (OLE) study for subjects with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag and who qualify for entry based upon participation in the prior study. Subjects who discontinue participation in a prior study due to safety issues related to study medication or who fail to complete study procedures will not be eligible to enter Study ROR-PH-303. Subjects who meet all OLE entry criteria will be enrolled and will receive ralinepag in addition to their pre-existing PAH disease-specific background therapy.

For subjects who are enrolled from an ongoing double-blind Phase 2 or Phase 3 ralinepag study, a 16-week blinded Dose Titration Period will be completed following enrollment into the OLE. Subjects previously on ralinepag will continue on the same dose during the Dose Titration Period as received in the original study and will also initiate placebo treatment in the OLE.

Subjects who are enrolled from a non-blinded study or another OLE will not participate in the blinded Dose Titration Period in Study ROR-PH-303 but will be enrolled directly into the Treatment Period and continue on the dose of ralinepag received in the original study.

All subjects will receive ralinepag in the OLE study until premature discontinuation of ralinepag due to an AE/serious adverse event (SAE) or other reason, marketing approval of ralinepag is granted in the region in which the study is conducted, or the study is discontinued by the Sponsor.

Eligibility criteria: Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study.
4. Both male and female subjects agree to use a medically acceptable method of contraception throughout the entire study period from informed consent through the 30 day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (i.e., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag.

Exclusion Criteria:

1. Subjects who prematurely discontinued investigational medicinal product (IMP) due to a drug-related AE/SAE or tolerability issue in the preceding ralinepag study in which they were enrolled, or subjects who did not complete all protocol defined study procedures at a Study Drug Termination Visit or End of Study Visit in the preceding ralinepag study.
2. Subjects who withdrew consent during participation in another ralinepag study.
3. Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit), or are lactating or breastfeeding.
4. Subjects who have undergone lung or heart/lung transplant or the initiation of long-term parenteral or inhaled therapy with a prostacyclin during the time since participation in their original ralinepag study.
5. Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.

Primary outcomes:
measure: Number of subjects with treatment-emergent adverse events [Safety and Tolerability]
timeFrame: Up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center-Norton Thoracic Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: La Jolla
country: United States
facility: UCSD Health Sciences
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group
state: Florida
city: Orlando
country: United States
facility: Investigational Drug Services, AdventHealth Orlando (Drug Shipment Address)
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Austell
country: United States
facility: Piedmont Healthcare Pulmonary and Critical Care Research
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Ascension Alexian Brothers
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Indianapolis
country: United States
facility: Community Heart and Vascular Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Medical Group, Inc.
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Research Center
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: South Portland
country: United States
facility: Chest Medicine Associates
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Mineola
country: United States
facility: Winthrop Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Weill-Cornell-New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati-Medical Science Building
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Clinic-Pulmonary West
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Knoxville
country: United States
facility: StatCare Pulmonary Consultants
state: Tennessee
city: Austin
country: United States
facility: Ascension Texas Cardiovascular
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Burlington
country: United States
facility: Vermont Lung Center
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic Pulmonary and Sleep Medicine
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/Froedtert Hospital
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano
state: Buenos Aires
city: Santa Fe
country: Argentina
facility: Hospital PROVINCIAL "Dr. Jose Maria Cullen"
state: Santa Fe De La Vera Cruz
city: Rosario
country: Argentina
facility: Sanatorio Parque
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Sanatorio de la Trinidad Mitre
city: Caba
country: Argentina
facility: Cardiologia Palmero
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Fundacion Respirar
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Fundacion Favaloro
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba S.A
city: Corrientes
country: Argentina
facility: Instituto de Cardiologia de Corrientes
city: Córdoba
country: Argentina
facility: Hospital Italiano de Cordoba
city: Mar Del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie University
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Perth
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1
city: Wien
country: Austria
facility: AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires de Bruxelles Hopital Erasme
city: Leuven
country: Belgium
facility: UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49
city: Goiânia
country: Brazil
facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
state: Goias
city: Belo Horizonte
country: Brazil
facility: Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
state: MG
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUC-RS
state: R.S
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
state: RS
city: Botucatu
country: Brazil
facility: UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Sao Paulo
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Coracao
state: SP
city: Sofia
country: Bulgaria
facility: MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.
city: Sofia
country: Bulgaria
facility: MHAT "Sveta Anna" Sofia AD
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: London
country: Canada
facility: LHSC - Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network-Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: SMBD Jewish General Hospital d/b/a Jewish General Hospital
state: Quebec
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
state: Quebec
city: Providencia
country: Chile
facility: Instiuto Nacional del Torax
state: Santiago De Chile
city: Beijing
country: China
facility: Beijing Shijitan Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6
city: Zagreb
country: Croatia
facility: University Clinic for Pulmonary Diseases, Jordanovac 104
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital (Rigshospitalet)
city: Århus
country: Denmark
facility: Århus Universitetshospital
city: Strasbourg
country: France
facility: CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital
state: Bas Rhin
city: Grenoble
country: France
facility: CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne
state: Isere
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond
state: Loire
city: Vandoeuvre les Nancy
country: France
facility: CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan
state: Meurthe Et Moselle
city: Bron cedex
country: France
facility: CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel
state: Rhone
city: Rouen cedex
country: France
facility: CHU de Rouen - Hôpital Charles Nicolle
state: Seine Maritime
city: Le Kremlin-Bicêtre
country: France
facility: Groupement Hospitalier Sud - Hôpital Bicêtre, Service de Pneumologie, 78 Avenue du General Leclerc
state: Val De Marne
city: Besançon Cedex
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Brest cedex 2
country: France
facility: CHU de Brest - Hôpital de la Cavale Blanche
city: Lille Cedex
country: France
facility: CHRU de Lille - Hopital Cardiologique
city: Marseille
country: France
facility: Hôpital Nord - CHU Marseille
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie
state: Baden-Württemberg
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
state: Mecklenburg-Vorpommern
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1
state: Rheinland Pfalz
city: Homburg
country: Germany
facility: Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41
state: Saarland
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie
state: Sachsen
city: Donaueschingen
country: Germany
facility: Schwarzwald-Baar Klinikum
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis
city: Athens
country: Greece
facility: "Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue
city: Chaidari
country: Greece
facility: University General Hospital Attikon
city: Thessaloniki
country: Greece
facility: AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street
city: Budapest
country: Hungary
facility: Gottsegen György Országos Kardiovaszkuláris Intézet
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center, 7 Michal st.
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem Medical Center, Kiryat Hadassah
city: Kfar- Sava
country: Israel
facility: Meir Medical Center, 59 Tshernichovski st.
city: Petach Tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center, 6 Weizmann St.
city: Palermo
country: Italy
facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
state: PA
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1
city: Genova
country: Italy
facility: IRCC Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35
city: Milan
country: Italy
facility: Centro Cardiologico Monzino, IRCCS U.O. Scompenso
city: Monza
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
city: Incheon
country: Korea, Republic of
facility: Gachon University Hospital Gil Medical Center
state: Namdong-gu
city: Mexico
country: Mexico
facility: Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera
state: Distrito Federal
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: CICUM San Miguel
state: Jalisco
city: Monterrey
country: Mexico
facility: Unidad de Investigacion Clinica en Medicina, S.C.
state: N.l.
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum, De Boelelaan 1117
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80
city: Otwock
country: Poland
facility: NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2
city: Wroclaw
country: Poland
facility: Premium Clinic Wrocław CM, Podwale 83/17
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, E.P.E
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra, E.P.E.
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente
city: Porto
country: Portugal
facility: Centro Hospitalar de Santo António, E.P.E.
city: Bucharest
country: Romania
facility: Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258
city: Bucuresti
country: Romania
facility: Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5
city: Cluj-Napoca
country: Romania
facility: Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21
city: Timisoara
country: Romania
facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia, Koste Todorovica 8
city: Belgrade
country: Serbia
facility: Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology
city: Sremska Kamenica
country: Serbia
facility: Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Heart Centre
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona, C/ Villarroel, 170
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Linköping
country: Sweden
facility: Linköping Universitetssjukhuset
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus, Hjärtcentrum
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Eskişehir
country: Turkey
facility: Osmangazi Uni Medical Faculty
state: Odumpazari
city: Adana
country: Turkey
facility: Balcalı, Çukurova Üniversitesi Kardiyoloji ABD
state: Saricam
city: Mersin
country: Turkey
facility: Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü
state: Yenisehir
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty Hospital
city: Bursa
country: Turkey
facility: Uludag Universitesi Tip Fakültesi, Gorukle Kampusu
city: Istanbul
country: Turkey
facility: Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10
city: Izmir
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova
city: Dnipro
country: Ukraine
facility: CE Dniprop RCC&C Center of Dniprop RC Dept of Card SI DMA of MOHU, Chair of Internal Medicine 3, 28, Knyazya Volodymyra Velykogo St.
city: Kyiv
country: Ukraine
facility: SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.
city: Lviv
country: Ukraine
facility: Communal Noncommercial Enterprise of Lviv Regional Council Lviv Clinical Hospital, Dept of Cardiology, D.Halytskyi Lviv NMU, Ch of Internal Medicine #1, 7, Chernihivska str.
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust, Pond Street
state: Greater London
city: London
country: United Kingdom
facility: Royal Brompton Hospital
state: Greater London
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital
state: Tyne And Wear
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
state: West Dunbartonshire
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
References: