A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
Study Purpose
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Inclusion Criteria:
1. At least 18 years of age. 2. 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. 3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 4. Primary diagnosis of symptomatic PAH. 5. Has had a right heart catheterization (RHC) performed at or within 3 years prior to Screening (RHC will be performed during Screening if not available) that is consistent with the diagnosis of PAH. 6. Has WHO/ NYHA functional class II to IV symptoms. 7. If on PAH-specific background oral therapy, subject is on stable therapy with either an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator. 8. Has a 6MWD of ≥150 meters. 9. If taking concomitant medications that may affect the clinical manifestations of PAH (eg, calcium channel blockers, diuretics, digoxin, or L arginine supplementation, beta blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers), must be on a stable dose for at least 30 days prior to the Baseline Visit and the dosage maintained throughout the study. The exception is that the dose of diuretics must be stable for at least the 10 days prior to Baseline. 10. Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through to 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 during the study and for 30 days after the last dose of IMP. Eligible male subjects must agree not to participate in sperm donation for 90 days after the last dose of IMP.Exclusion Criteria:
1. For subjects with known HIV-associated PAH, a cluster designation 4 (CD4+) T-cell count <200/mm3 within 90 days of Baseline. 2. Must not have 3 or more left ventricular dysfunction risk factors as defined in the study protocol. 3. Has evidence of more than mild lung disease on pulmonary function tests performed within 180 days prior to, or during Screening. 4. Has evidence of thromboembolic disease as determined by a V/Q lung scan or local standard of care diagnostic evaluation at or after diagnosis of PAH. 5. Current diagnosis of ongoing and clinically significant sleep apnea as defined by the Investigator. 6. Male subjects with a corrected QT interval using Fridericia's formula (QTcF) >450 msec and female subjects with a QTcF >470 msec on ECG recorded at Screening and analyzed by the central ECG laboratory. Subjects with evidence of intraventricular conduction delay, defined as a QRS interval greater than 110 msec, will be excluded if the QTcF is >500 msec for both males and females. 7. Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy). 8. Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). 9. Subjects with alanine aminotransferase or aspartate aminotransferase ≥3 times the upper limit of normal (ULN) or total bilirubin ≥2 × ULN at Screening. 10. Chronic renal insufficiency as defined by serum creatinine >2.5 mg/dL or requiring dialysis at Screening. 11. Hemoglobin concentration <9 g/dL at Screening. 12. Subjects treated with an IV or SC prostacyclin pathway agent (eg, epoprostenol, treprostinil, or iloprost) for PAH at any time prior to Baseline (use in vasoreactive testing is permitted). 13. Subjects currently on or who were treated with an inhaled or oral prostacyclin pathway agent (iloprost, treprostinil, beraprost, or selexipag) for >6 months or within 90 days prior to Baseline. 14. Subject has pulmonary veno-occlusive disease. 15. Malignancy diagnosed and/or treated within 5 years prior to Screening, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent. 16. Subject tests positive for amphetamine, cocaine, methamphetamine, methylenedioxymethamphetamine or phencyclidine in urine drug screen performed at Screening, or has a recent history (6 months) of alcohol or drug abuse. A subject will not be excluded due to a positive drug screen caused by prescribed medications. 17. Initiation or discontinuation of a cardio-pulmonary rehabilitation program based upon exercise within 90 days prior to Screening and/or planned during study participation. 18. Prior participation in any study of ralinepag or participation in another interventional clinical study with medicinal products within 30 days prior to Screening. Concurrent participation in registry or observational studies is allowed, as long as the subject can fulfill all other entry criteria and comply with all study procedures. 19. Any reason that, in the opinion of the Investigator or Medical Monitor, precludes the subject from participating in the study (eg, any previous or intercurrent medical condition) that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation. 20. Known hypersensitivity to ralinepag or any of the excipients. 21. Life expectancy <12 months based on the Investigator's opinion. 22. Women who are pregnant, lactating or breast-feeding.Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03626688 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
United Therapeutics |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Romania, Serbia, Singapore, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
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 |
Study ROR-PH-301 is a multicenter, randomized, double-blind, placebo-controlled study. Subjects who meet entry criteria will be randomly allocated 1:1 to receive ralinepag or placebo, in addition to their standard of care or PAH-specific background therapy, as applicable. The primary endpoint is the time (in days) from randomization to the first adjudicated protocol-defined clinical worsening event. All primary endpoint events will be adjudicated by an independent Clinical Event Committee (CEC) in a blinded fashion. Subjects who have a confirmed primary endpoint event adjudicated by the CEC at any time during the study and all subjects on treatment at the conclusion of the study who have completed the Week 28 Visit (after the target number of confirmed events is achieved) will have the option to enroll in an open-label extension (OLE) study. Subjects who do not choose to participate in the OLE study will discontinue study drug and should remain in the study for long-term follow-up of survival status and will receive standard of care PAH treatment, at the discretion of the treating physician.
Arms
Experimental: Ralinepag
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.
Placebo Comparator: Placebo
Matching placebo tablets (oral)
Interventions
Drug: - Ralinepag
Active
Drug: - Placebo
Placebo
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Status
Withdrawn
Address
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
Status
Recruiting
Address
University of Arizona
Tucson, Arizona, 85724
Status
Recruiting
Address
UCSD Health Sciences
La Jolla, California, 92037
Status
Completed
Address
Loma Linda University Medical Center
Loma Linda, California, 92354
Status
Recruiting
Address
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90024
Status
Completed
Address
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Status
Recruiting
Address
Keck Hospital of USC
Los Angeles, California, 90033
Status
Completed
Address
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Status
Recruiting
Address
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Status
Recruiting
Address
University of California, Irvine
Orange, California, 19103
Status
Recruiting
Address
University of California Davis Medical Center
Sacramento, California, 95817
Status
Recruiting
Address
SBPA Research LLC
Santa Barbara, California, 93105
Status
Recruiting
Address
Stanford Healthcare
Stanford, California, 94305
Status
Completed
Address
LA Biomedical Research Institute Harbor-UCLA Medical Center
Torrance, California, 90502
Status
Recruiting
Address
University of Colorado Hospital
Aurora, Colorado, 80045
Status
Recruiting
Address
National Jewish Health
Denver, Colorado, 80206
Status
Recruiting
Address
University of Florida
Gainesville, Florida, 32610
Status
Withdrawn
Address
Mayo Clinic Florida
Jacksonville, Florida, 32224
Status
Completed
Address
University of Miami
Miami, Florida, 33136
Status
Recruiting
Address
Central Florida Pulmonary Group
Orlando, Florida, 32803
Status
Withdrawn
Address
AdventHealth Orlando
Orlando, Florida, 32804
Status
Recruiting
Address
Cleveland Clinic Florida
Weston, Florida, 33331
Status
Recruiting
Address
Emory University Hospital
Atlanta, Georgia, 30322
Status
Recruiting
Address
Piedmont Healthcare Pulmonary and Critical Care Research
Austell, Georgia, 30106
Status
Recruiting
Address
University of Chicago Medical Center
Chicago, Illinois, 60637
Status
Recruiting
Address
Ascension Alexian Brothers
Elk Grove Village, Illinois, 60007
Status
Completed
Address
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Status
Recruiting
Address
Community Health Network Cancer Center North
Indianapolis, Indiana, 46250
Status
Recruiting
Address
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46260
Status
Recruiting
Address
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Status
Active, not recruiting
Address
Kentuckiana Pulmonary Research Center
Louisville, Kentucky, 40202
Status
Completed
Address
Ochsner Medical Center
New Orleans, Louisiana, 70121
Status
Completed
Address
Chest Medicine Associates
South Portland, Maine, 04106
Status
Recruiting
Address
University of Maryland Medical Center
Baltimore, Maryland, 21201
Status
Recruiting
Address
Tufts Medical Center
Boston, Massachusetts, 02111
Status
Recruiting
Address
Massachusetts General Hospital
Boston, Massachusetts, 02114
Status
Active, not recruiting
Address
Boston University Medical Center
Boston, Massachusetts, 02118
Status
Recruiting
Address
Spectrum Health Medical Group
Grand Rapids, Michigan, 49546
Status
Withdrawn
Address
Mayo Clinic
Rochester, Minnesota, 55905
Status
Recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Nebraska Medical Center
Omaha, Nebraska, 68198
Status
Recruiting
Address
University of New Mexico
Albuquerque, New Mexico, 87131
Status
Completed
Address
Winthrop Hospital
Mineola, New York, 11501
Status
Recruiting
Address
NYU Langone Medical Center
New York, New York, 10016
Status
Completed
Address
Weill-Cornell-New York Presbyterian Hospital
New York, New York, 10021
Status
Completed
Address
Mount Sinai School of Medicine
New York, New York, 10029
Status
Recruiting
Address
University of Rochester
Rochester, New York, 14642
Status
Recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Recruiting
Address
East Carolina University
Greenville, North Carolina, 27834
Status
Recruiting
Address
University of Cincinnati-Medical Science Building
Cincinnati, Ohio, 45267
Status
Completed
Address
Cleveland Clinic
Cleveland, Ohio, 44195
Status
Recruiting
Address
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Status
Recruiting
Address
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Status
Active, not recruiting
Address
Oregon Clinic-Pulmonary West
Portland, Oregon, 97225
Status
Recruiting
Address
Oregon Health & Science University
Portland, Oregon, 97239
Status
Recruiting
Address
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Status
Completed
Address
Temple University
Philadelphia, Pennsylvania, 19140
Status
Recruiting
Address
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Status
Recruiting
Address
Statcare Pulmonary Consultants
Knoxville, Tennessee, 37919
Status
Recruiting
Address
Ascension Texas Cardiovascular
Austin, Texas, 78705
Status
Recruiting
Address
UT Southwestern Medical Center
Dallas, Texas, 75390
Status
Recruiting
Address
Memorial Hermann Hospital
Houston, Texas, 77030
Status
Recruiting
Address
The Methodist Hospital Research Institute
Houston, Texas, 77030
Status
Recruiting
Address
Vermont Lung Center
Colchester, Vermont, 05446
Status
Completed
Address
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Status
Completed
Address
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Status
Recruiting
Address
Carilion Clinic Pulmonary and Sleep Medicine
Roanoke, Virginia, 24014
Status
Recruiting
Address
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226
International Sites
Status
Recruiting
Address
Hospital Italiano
Ciudad Autonoma Buenos Aires, Buenos Aires, C1181ACH
Status
Recruiting
Address
Instituto de Investigaciones Clinicas Mar del Plata
Mar Del Plata, Buenos Aires, 7600
Status
Recruiting
Address
Sanatorio Parque S.A.
Rosario, Santa Fe, S2000DSV
Status
Recruiting
Address
Sanatorio de la Trinidad Mitre
Buenos Aires, , C1039AAO
Status
Recruiting
Address
Cardiologia Palmero
Caba, , 1425
Status
Recruiting
Address
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, , 1280
Status
Completed
Address
Fundacion Respirar
Ciudad Autonoma Buenos Aires, , 1426
Status
Recruiting
Address
Fundacion Favaloro
Ciudad Autonoma Buenos Aires, , C1093AAS
Status
Recruiting
Address
Hospital Italiano de Cordoba
Cordoba, , X5004BAL
Status
Recruiting
Address
Hospital Privado Centro Medico de Cordoba S.A
Cordoba, , X5016KEH
Status
Recruiting
Address
Instituto de Cardiologia de Corrientes
Corrientes, ,
Status
Recruiting
Address
Hospital PROVINCIAL "Dr. Jose Maria Cullen"
Santa Fe, , 3000
Status
Active, not recruiting
Address
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Status
Recruiting
Address
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Status
Recruiting
Address
Nepean Hospital
Kingswood, New South Wales, 2751
Status
Recruiting
Address
Macquarie University
Macquarie, New South Wales, 2109
Status
Recruiting
Address
Westmead Hospital
Sydney, New South Wales, 2145
Status
Recruiting
Address
The Prince Charles Hospital
Chermside, Queensland, 4032
Status
Completed
Address
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Status
Recruiting
Address
Royal Hobart Hospital
Hobart, Tasmania, 7000
Status
Recruiting
Address
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Status
Recruiting
Address
The Alfred Hospital
Melbourne, Victoria, 3004
Status
Recruiting
Address
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Status
Recruiting
Address
Medizinische Universität Innsbruck
Innsbruck, , 6020
Status
Recruiting
Address
Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1
Linz, , 4020
Status
Recruiting
Address
AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20
Vienna, , 1090
Status
Recruiting
Address
Cliniques Universitaires de Bruxelles Hopital Erasme
Bruxelles, , 1070
Status
Recruiting
Address
UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49
Leuven, , 3000
Status
Recruiting
Address
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, Goias, 74605-020
Status
Recruiting
Address
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte, MG, 30441-070
Status
Recruiting
Address
Hospital Sao Lucas da PUC-RS
Porto Alegre, R.S, 90610-000
Status
Recruiting
Address
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, RS, 90035-074
Status
Recruiting
Address
UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu
Botucatu, Sao Paulo, 18618-687
Status
Recruiting
Address
Hospital Sao Paulo
Sao Paulo, SP, 04037-002
Status
Recruiting
Address
Instituto do Coracao
Sao Paulo, SP, 05403-000
Status
Recruiting
Address
MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.
Sofia, , 1309
Status
Recruiting
Address
MHAT "Sveta Anna" Sofia AD
Sofia, , 1750
Status
Recruiting
Address
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4
Status
Recruiting
Address
LHSC - Victoria Hospital
London, Ontario, N6A 5W9
Status
Recruiting
Address
University Health Network-Toronto General Hospital
Toronto, Ontario, M5G 2N2
Status
Completed
Address
SMBD Jewish General Hospital d/b/a Jewish General Hospital
Montreal, Quebec, H3T1E2
Status
Recruiting
Address
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5
Status
Recruiting
Address
Instiuto Nacional del Torax
Providencia, Santiago De Chile, 7500691
Status
Active, not recruiting
Address
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing, 100038
Status
Active, not recruiting
Address
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Status
Active, not recruiting
Address
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Status
Active, not recruiting
Address
Shanghai Pulmonary Hospital
Shanghai, Shanghai, 200443
Status
Active, not recruiting
Address
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, , 100037
Status
Withdrawn
Address
Fuwai Central China Cardiovascular Hospital
Zhengzhou, , 450000
Status
Completed
Address
Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6
Zagreb, , 10000
Status
Completed
Address
University Clinic for Pulmonary Diseases, Jordanovac 104
Zagreb, , 10000
Status
Recruiting
Address
Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2
Praha 2, , 128 08
Status
Recruiting
Address
Copenhagen University Hospital (Rigshospitalet)
Copenhagen, , 2100
Status
Recruiting
Address
Århus Universitetshospital
Århus, , 8200
Status
Recruiting
Address
CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital
Strasbourg, Bas Rhin, 67091
Status
Completed
Address
CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne
Grenoble, Isere, 38048
Status
Active, not recruiting
Address
CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond
Saint-Étienne, Loire, 42005
Status
Recruiting
Address
CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan
Vandoeuvre les Nancy, Meurthe Et Moselle, 54511
Status
Recruiting
Address
CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel
Bron cedex, Rhone, 69677
Status
Recruiting
Address
CHU de Rouen - Hôpital Charles Nicolle
Rouen cedex, Seine Maritime, 76031
Status
Completed
Address
Groupement Hospitalier Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, Val De Marne, 94275
Status
Recruiting
Address
CHU Besançon - Hôpital Jean Minjoz
Besançon Cedex, , 25030
Status
Recruiting
Address
CHU de Brest - Hôpital de la Cavale Blanche
Brest cedex 2, , 29609
Status
Recruiting
Address
CHRU de Lille - Hopital Cardiologique
Lille Cedex, , 59037
Status
Completed
Address
Hôpital Nord - CHU Marseille
Marseille, , 13015
Status
Recruiting
Address
Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie
Heidelberg, Baden-Württemberg, 69126
Status
Recruiting
Address
Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
Status
Recruiting
Address
Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1
Mainz, Rheinland Pfalz, 55131
Status
Recruiting
Address
Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41
Homburg, Saarland, 66424
Status
Recruiting
Address
Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie
Leipzig, Sachsen, 04103
Status
Recruiting
Address
Schwarzwald-Baar Klinikum
Donaueschingen, , 78166
Status
Recruiting
Address
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, , 01307
Status
Recruiting
Address
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , 20246
Status
Recruiting
Address
"Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue
Athens, Kallithea, 17674
Status
Completed
Address
University General Hospital of Alexandroupolis
Alexandroupolis, , 68100
Status
Completed
Address
University General Hospital Attikon
Chaidari, , 12462
Status
Recruiting
Address
AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street
Thessaloniki, , 54636
Status
Recruiting
Address
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Családorvosi Intézet és Rendelő
Szeged, Csongrád-Csanád, Hungary
Status
Recruiting
Address
Gottsegen György Országos Kardiovaszkuláris Intézet
Budapest, , 1096
Status
Recruiting
Address
Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.
Pecs, , 7624
Status
Recruiting
Address
The Lady Davis Carmel Medical Center, 7 Michal st.
Haifa, , 3436212
Status
Recruiting
Address
Hadassah Ein Kerem Medical Center, Kiryat Hadassah
Jerusalem, , 9112001
Status
Recruiting
Address
Meir Medical Center, 59 Tshernichovski st.
Kfar- Sava, , 4428164
Status
Recruiting
Address
Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor
Petach Tikva, , 4941492
Status
Recruiting
Address
Tel Aviv Sourasky Medical Center, 6 Weizmann St.
Tel Aviv, , 6423906
Status
Recruiting
Address
Istituto Mediterraneo Trapianti e Terapie a Alta Specializzazione (IRCCS-ISMETT)
Palermo, PA, 90127
Status
Completed
Address
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1
Foggia, , 71100
Status
Recruiting
Address
IRCC Ospedale Policlinico San Martino
Genova, , 16132
Status
Completed
Address
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35
Milano, , 20122
Status
Completed
Address
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza, , 20900
Status
Recruiting
Address
Fondazione IRCCS Policlinico San Matteo
Pavia, , 27100
Status
Recruiting
Address
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155
Roma, , 00161
Status
Recruiting
Address
Samsung Medical Center
Seoul, Gangnam-gu, 06351
Status
Recruiting
Address
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Status
Recruiting
Address
Gachon University Hospital Gil Medical Center
Incheon, Namdong-gu, 21565
Status
Recruiting
Address
Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera
Mexico, Distrito Federal, 14080
Status
Recruiting
Address
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
Mexico, Distrito Federal, 14080
Status
Recruiting
Address
CICUM San Miguel
Guadalajara, Jalisco, 44160
Status
Recruiting
Address
Unidad de Investigacion Clinica en Medicina, S.C.
Monterrey, N.l., 64718
Status
Recruiting
Address
VU Medisch Centrum, De Boelelaan 1117
Amsterdam, , 1081 HV
Status
Recruiting
Address
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a
Bialystok, , 15-276
Status
Completed
Address
Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80
Krakow, , 31-202
Status
Completed
Address
NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18
Otwock, , 05-400
Status
Recruiting
Address
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2
Poznan, , 61-848
Status
Active, not recruiting
Address
Premium Clinic Wrocław CM, Podwale 83/17
Wroclaw, , 50-414
Status
Recruiting
Address
Hospital Garcia de Orta, E.P.E
Almada, , 2805-267
Status
Recruiting
Address
Centro Hospitalar e Universitário de Coimbra, E.P.E.
Coimbra, , 3000-075
Status
Recruiting
Address
Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente
Lisboa, , 1769-001
Status
Recruiting
Address
Centro Hospitalar de Santo António E.P.E.
Porto, , 4099-001
Status
Recruiting
Address
Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258
Bucharest, , 022328
Status
Recruiting
Address
Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5
Bucuresti, , 050159
Status
Recruiting
Address
Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21
Cluj-Napoca, , 400001
Status
Recruiting
Address
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13
Timisoara, , 300310
Status
Recruiting
Address
Clinical Center of Serbia, Koste Todorovica 8
Belgrade, , 11000
Status
Recruiting
Address
Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology
Belgrade, , 11080
Status
Recruiting
Address
Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4
Sremska Kamenica, , 21204
Status
Recruiting
Address
National University Hospital
Singapore, , 119074
Status
Recruiting
Address
National Heart Centre
Singapore, , 169609
Status
Completed
Address
Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia
Barcelona, , 08035
Status
Recruiting
Address
Hospital Clinic de Barcelona, C/ Villarroel, 170
Barcelona, , 08036
Status
Recruiting
Address
Hospital Universitario 12 de Octubre
Madrid, , 28041
Status
Recruiting
Address
Hospoital Universitari i Politecnic La Fe
Valencia, , 46026
Status
Completed
Address
Sahlgrenska Universitetssjukhuset
Göteborg, , 41345
Status
Completed
Address
Linköping Universitetssjukhuset
Linköping, , 58185
Status
Completed
Address
Norrlands Universitetssjukhus, Hjärtcentrum
Umeå, , 90185
Status
Recruiting
Address
National Cheng Kung University Hospital
Tainan, , 704
Status
Recruiting
Address
National Taiwan University Hospital
Taipei, , 10002
Status
Recruiting
Address
Osmangazi Uni Medical Faculty
Eskişehir, Odunpazari, 26040
Status
Recruiting
Address
Balcalı, Çukurova Üniversitesi Kardiyoloji ABD
Adana, Saricam, 01330
Status
Recruiting
Address
Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü
Mersin, Yenisehir, 33343
Status
Recruiting
Address
Gazi University Medical Faculty Hospital
Ankara, , 06560
Status
Recruiting
Address
Uludag Universitesi Tip Fakültesi, Gorukle Kampusu
Bursa, , 16059
Status
Recruiting
Address
Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10
Istanbul, , 34899
Status
Recruiting
Address
Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova
Izmir, , 35340
Status
Recruiting
Address
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.
Dnipro, , 49070
Status
Completed
Address
SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.
Kyiv, , 03680
Status
Completed
Address
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.
Lviv, , 79010
Status
Recruiting
Address
Royal Free London NHS Foundation Trust, Pond Street
London, Greater London, NW3 2QG
Status
Recruiting
Address
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital
Newcastle upon Tyne, Tyne & Wear, NE7 7DN
Status
Recruiting
Address
Golden Jubilee National Hospital
Glasgow, West Dunbartonshire, G81 4DY
Status
Recruiting
Address
Royal Brompton Hospital
London, , SW3 6NP
Status
Recruiting
Address
Imperial College Healthcare NHS Trust
London, , W12 0HS