MedPath

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

Phase 3
Recruiting
Conditions
Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Hypertension
Familial Primary Pulmonary Hypertension
PAH
Connective Tissue Diseases
Lung Diseases
Interventions
Drug: Placebo
Drug: Ralinepag
Registration Number
NCT03626688
Lead Sponsor
United Therapeutics
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
1000
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboMatching placebo tablets (oral)
RalinepagRalinepagRalinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.
Primary Outcome Measures
NameTimeMethod
Time from randomization to the first adjudicated protocol-defined clinical worsening eventThe study duration was event-based. This parameter was assessed from randomization until the conclusion of the study, up to 3 years

Clinical worsening events are defined as death, nonelective hospital admission for worsening PAH (further defined in clinical study protocol), initiation of parenteral or inhaled prostacyclin pathway agent for treatment of worsening PAH, disease progression (further defined in clinical study protocol), or unsatisfactory long-term clinical response (further defined in clinical study protocol).

Secondary Outcome Measures
NameTimeMethod
Change from Baseline in 6-minute walk distance (6MWD)Baseline to Week 28

6MWD was measured at Baseline (prior to starting study drug) and Week 4, 8, 12, and 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.

Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) risk scoreBaseline to Week 28

Data from NT-proBNP, 6MWD, WHO/NYHA functional class, systolic blood pressure, heart rate, and estimated glomerular filtration rate values collected at visits through Week 28 were used to calculate the composite REVEAL risk score.

Time to first all-cause nonelective hospitalizationThe study duration was event-based. This parameter was assessed from randomization until the conclusion of the study (when the target number of adjudicated events was achieved, as defined in the study protocol).

All nonelective hopsitalizations during the study period were collected.

Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)Baseline to Week 28

NT-proBNP was measured at Baseline (prior to starting study drug) and Week 4, 8, 12, and 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.

Change from Baseline in WHO/New York Heart Association (NYHA) Functional ClassBaseline to Week 28

The severity of PAH was graded according to the functional status of the subject and assessed at every visit.

Shift and proportion of subjects who attain all 3 of the following: NT-proBNP level <300 pg/mL, 6MWD >440 meters, and WHO/NYHA Functional Class I or IIBaseline to Week 28

Data from NT-proBNP, 6MWD, and WHO/NYHA functional class assessment were compiled as a composite endpoint at visits through Week 28.

Clinical improvement as defined by the absence of clinical worsening and fulfillment of at least 2 of the 3 of the following: increase in 6MWD ≥10% or ≥30 m, improvement to or maintenance of WHO FC I or II, and decrease in NT-proBNP by at least 30%.Baseline to Week 28

Data from 6MWD, WHO/NYHA functional class assessment, and NT-proBNP were compiled as a composite endpoint at visits through Week 28.

Safety and tolerability of ralinepag in subjects with PAHBaseline to Week 28

Safety and tolerability were assessed by adverse events.

Change from Baseline in health-related quality of life as measured by patient-reported outcomes.Baseline to Week 28

Quality of life was assessed using patient-reported outcomes at Baseline (prior to starting study drug) and Week 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.

Time to all-cause mortalityThe study duration was event-based. This parameter was assessed from randomization until the conclusion of the study (when the target number of adjudicated events was achieved, as defined in the study protocol).

All deaths during the study period were collected.

Change from Baseline in heart rate recovery (HRR) following completion of the 6MWTBaseline to Week 28

HRR was measured at Baseline (prior to starting study drug) and Week 4, 8, 12, and 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.

Trial Locations

Locations (214)

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

St. Joseph's Hospital and Medical Center

🇺🇸

Phoenix, Arizona, United States

Mayo Clinic Scottsdale

🇺🇸

Scottsdale, Arizona, United States

University of Arizona

🇺🇸

Tucson, Arizona, United States

UCSD Health Sciences

🇺🇸

La Jolla, California, United States

Loma Linda University Medical Center

🇺🇸

Loma Linda, California, United States

Ronald Reagan UCLA Medical Center

🇺🇸

Los Angeles, California, United States

Kaiser Permanente Los Angeles Medical Center

🇺🇸

Los Angeles, California, United States

Keck Hospital of USC

🇺🇸

Los Angeles, California, United States

Cedars-Sinai Medical Center

🇺🇸

Los Angeles, California, United States

VA Greater Los Angeles Healthcare System

🇺🇸

Los Angeles, California, United States

University of California, Irvine

🇺🇸

Orange, California, United States

University of California Davis Medical Center

🇺🇸

Sacramento, California, United States

SBPA Research LLC

🇺🇸

Santa Barbara, California, United States

Stanford Healthcare

🇺🇸

Stanford, California, United States

LA Biomedical Research Institute Harbor-UCLA Medical Center

🇺🇸

Torrance, California, United States

University of Colorado Hospital

🇺🇸

Aurora, Colorado, United States

National Jewish Health

🇺🇸

Denver, Colorado, United States

University of Florida

🇺🇸

Gainesville, Florida, United States

Mayo Clinic Florida

🇺🇸

Jacksonville, Florida, United States

University of Miami

🇺🇸

Miami, Florida, United States

Central Florida Pulmonary Group

🇺🇸

Orlando, Florida, United States

AdventHealth Orlando

🇺🇸

Orlando, Florida, United States

Cleveland Clinic Florida

🇺🇸

Weston, Florida, United States

Emory University Hospital

🇺🇸

Atlanta, Georgia, United States

Piedmont Healthcare Pulmonary and Critical Care Research

🇺🇸

Austell, Georgia, United States

University of Chicago Medical Center

🇺🇸

Chicago, Illinois, United States

Ascension Alexian Brothers

🇺🇸

Elk Grove Village, Illinois, United States

Indiana University School of Medicine

🇺🇸

Indianapolis, Indiana, United States

Community Health Network Cancer Center North

🇺🇸

Indianapolis, Indiana, United States

St. Vincent Medical Group, Inc.

🇺🇸

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

🇺🇸

Iowa City, Iowa, United States

Kentuckiana Pulmonary Research Center

🇺🇸

Louisville, Kentucky, United States

Ochsner Medical Center

🇺🇸

New Orleans, Louisiana, United States

Chest Medicine Associates

🇺🇸

South Portland, Maine, United States

University of Maryland Medical Center

🇺🇸

Baltimore, Maryland, United States

Tufts Medical Center

🇺🇸

Boston, Massachusetts, United States

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

Boston University Medical Center

🇺🇸

Boston, Massachusetts, United States

Spectrum Health Medical Group

🇺🇸

Grand Rapids, Michigan, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

Nebraska Medical Center

🇺🇸

Omaha, Nebraska, United States

University of New Mexico

🇺🇸

Albuquerque, New Mexico, United States

Winthrop Hospital

🇺🇸

Mineola, New York, United States

NYU Langone Medical Center

🇺🇸

New York, New York, United States

Weill-Cornell-New York Presbyterian Hospital

🇺🇸

New York, New York, United States

Mount Sinai School of Medicine

🇺🇸

New York, New York, United States

University of Rochester

🇺🇸

Rochester, New York, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

East Carolina University

🇺🇸

Greenville, North Carolina, United States

University of Cincinnati-Medical Science Building

🇺🇸

Cincinnati, Ohio, United States

Cleveland Clinic

🇺🇸

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

🇺🇸

Columbus, Ohio, United States

Integris Baptist Medical Center

🇺🇸

Oklahoma City, Oklahoma, United States

Oregon Clinic-Pulmonary West

🇺🇸

Portland, Oregon, United States

Oregon Health & Science University

🇺🇸

Portland, Oregon, United States

University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

Temple University

🇺🇸

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

🇺🇸

Pittsburgh, Pennsylvania, United States

Statcare Pulmonary Consultants

🇺🇸

Knoxville, Tennessee, United States

Ascension Texas Cardiovascular

🇺🇸

Austin, Texas, United States

Baylor University Medical Center

🇺🇸

Dallas, Texas, United States

UT Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

Memorial Hermann Hospital

🇺🇸

Houston, Texas, United States

The Methodist Hospital Research Institute

🇺🇸

Houston, Texas, United States

Vermont Lung Center

🇺🇸

Colchester, Vermont, United States

University of Virginia Medical Center

🇺🇸

Charlottesville, Virginia, United States

Sentara Cardiovascular Research Institute

🇺🇸

Norfolk, Virginia, United States

Carilion Clinic Pulmonary and Sleep Medicine

🇺🇸

Roanoke, Virginia, United States

Medical College of Wisconsin/Froedtert Hospital

🇺🇸

Milwaukee, Wisconsin, United States

Hospital Italiano

🇦🇷

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata

🇦🇷

Mar Del Plata, Buenos Aires, Argentina

Sanatorio Parque S.A.

🇦🇷

Rosario, Santa Fe, Argentina

Sanatorio de la Trinidad Mitre

🇦🇷

Buenos Aires, Argentina

Cardiologia Palmero

🇦🇷

Caba, Argentina

Hospital Britanico de Buenos Aires

🇦🇷

Ciudad Autonoma Buenos Aires, Argentina

Fundacion Respirar

🇦🇷

Ciudad Autonoma Buenos Aires, Argentina

Fundacion Favaloro

🇦🇷

Ciudad Autonoma Buenos Aires, Argentina

Hospital Italiano de Cordoba

🇦🇷

Cordoba, Argentina

Hospital Privado Centro Medico de Cordoba S.A

🇦🇷

Cordoba, Argentina

Instituto de Cardiologia de Corrientes

🇦🇷

Corrientes, Argentina

Hospital PROVINCIAL "Dr. Jose Maria Cullen"

🇦🇷

Santa Fe, Argentina

Royal Prince Alfred Hospital

🇦🇺

Camperdown, New South Wales, Australia

St Vincent's Hospital Sydney

🇦🇺

Darlinghurst, New South Wales, Australia

Nepean Hospital

🇦🇺

Kingswood, New South Wales, Australia

Macquarie University

🇦🇺

Macquarie, New South Wales, Australia

Westmead Hospital

🇦🇺

Sydney, New South Wales, Australia

The Prince Charles Hospital

🇦🇺

Chermside, Queensland, Australia

Princess Alexandra Hospital

🇦🇺

Woolloongabba, Queensland, Australia

Royal Hobart Hospital

🇦🇺

Hobart, Tasmania, Australia

St Vincent's Hospital Melbourne

🇦🇺

Fitzroy, Victoria, Australia

The Alfred Hospital

🇦🇺

Melbourne, Victoria, Australia

Fiona Stanley Hospital

🇦🇺

Murdoch, Western Australia, Australia

Medizinische Universität Innsbruck

🇦🇹

Innsbruck, Austria

Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1

🇦🇹

Linz, Austria

AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20

🇦🇹

Vienna, Austria

Cliniques Universitaires de Bruxelles Hopital Erasme

🇧🇪

Bruxelles, Belgium

UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49

🇧🇪

Leuven, Belgium

HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

🇧🇷

Goiânia, Goias, Brazil

Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

🇧🇷

Belo Horizonte, MG, Brazil

Hospital Sao Lucas da PUC-RS

🇧🇷

Porto Alegre, R.S, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

🇧🇷

Porto Alegre, RS, Brazil

UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu

🇧🇷

Botucatu, Sao Paulo, Brazil

Hospital Sao Paulo

🇧🇷

Sao Paulo, SP, Brazil

Instituto do Coracao

🇧🇷

Sao Paulo, SP, Brazil

MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.

🇧🇬

Sofia, Bulgaria

MHAT "Sveta Anna" Sofia AD

🇧🇬

Sofia, Bulgaria

Peter Lougheed Centre

🇨🇦

Calgary, Alberta, Canada

LHSC - Victoria Hospital

🇨🇦

London, Ontario, Canada

University Health Network-Toronto General Hospital

🇨🇦

Toronto, Ontario, Canada

SMBD Jewish General Hospital d/b/a Jewish General Hospital

🇨🇦

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

🇨🇦

Québec, Quebec, Canada

Instiuto Nacional del Torax

🇨🇱

Providencia, Santiago De Chile, Chile

Beijing Shijitan Hospital, Capital Medical University

🇨🇳

Beijing, Beijing, China

Guangdong Provincial People's Hospital

🇨🇳

Guangzhou, Guangdong, China

Xiangya Hospital Central South University

🇨🇳

Changsha, Hunan, China

Shanghai Pulmonary Hospital

🇨🇳

Shanghai, Shanghai, China

Fuwai Hospital, Chinese Academy of Medical Sciences

🇨🇳

Beijing, China

Fuwai Central China Cardiovascular Hospital

🇨🇳

Zhengzhou, China

Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6

🇭🇷

Zagreb, Croatia

University Clinic for Pulmonary Diseases, Jordanovac 104

🇭🇷

Zagreb, Croatia

Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2

🇨🇿

Praha 2, Czechia

Copenhagen University Hospital (Rigshospitalet)

🇩🇰

Copenhagen, Denmark

Århus Universitetshospital

🇩🇰

Århus, Denmark

CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital

🇫🇷

Strasbourg, Bas Rhin, France

CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne

🇫🇷

Grenoble, Isere, France

CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond

🇫🇷

Saint-Étienne, Loire, France

CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan

🇫🇷

Vandoeuvre les Nancy, Meurthe Et Moselle, France

CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel

🇫🇷

Bron cedex, Rhone, France

CHU de Rouen - Hôpital Charles Nicolle

🇫🇷

Rouen cedex, Seine Maritime, France

Groupement Hospitalier Sud - Hôpital Bicêtre

🇫🇷

Le Kremlin-Bicêtre, Val De Marne, France

CHU Besançon - Hôpital Jean Minjoz

🇫🇷

Besançon Cedex, France

CHU de Brest - Hôpital de la Cavale Blanche

🇫🇷

Brest cedex 2, France

CHRU de Lille - Hopital Cardiologique

🇫🇷

Lille Cedex, France

Hôpital Nord - CHU Marseille

🇫🇷

Marseille, France

Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie

🇩🇪

Heidelberg, Baden-Württemberg, Germany

Universitätsmedizin Greifswald

🇩🇪

Greifswald, Mecklenburg-Vorpommern, Germany

Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1

🇩🇪

Mainz, Rheinland Pfalz, Germany

Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41

🇩🇪

Homburg, Saarland, Germany

Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie

🇩🇪

Leipzig, Sachsen, Germany

Schwarzwald-Baar Klinikum

🇩🇪

Donaueschingen, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

🇩🇪

Dresden, Germany

Universitaetsklinikum Hamburg-Eppendorf

🇩🇪

Hamburg, Germany

"Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue

🇬🇷

Athens, Kallithea, Greece

University General Hospital of Alexandroupolis

🇬🇷

Alexandroupolis, Greece

University General Hospital Attikon

🇬🇷

Chaidari, Greece

AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street

🇬🇷

Thessaloniki, Greece

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Családorvosi Intézet és Rendelő

🇭🇺

Szeged, Csongrád-Csanád, Hungary

Gottsegen György Országos Kardiovaszkuláris Intézet

🇭🇺

Budapest, Hungary

Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.

🇭🇺

Pecs, Hungary

The Lady Davis Carmel Medical Center, 7 Michal st.

🇮🇱

Haifa, Israel

Hadassah Ein Kerem Medical Center, Kiryat Hadassah

🇮🇱

Jerusalem, Israel

Meir Medical Center, 59 Tshernichovski st.

🇮🇱

Kfar- Sava, Israel

Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor

🇮🇱

Petach Tikva, Israel

Tel Aviv Sourasky Medical Center, 6 Weizmann St.

🇮🇱

Tel Aviv, Israel

Istituto Mediterraneo Trapianti e Terapie a Alta Specializzazione (IRCCS-ISMETT)

🇮🇹

Palermo, PA, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1

🇮🇹

Foggia, Italy

IRCC Ospedale Policlinico San Martino

🇮🇹

Genova, Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35

🇮🇹

Milano, Italy

Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

🇮🇹

Monza, Italy

Fondazione IRCCS Policlinico San Matteo

🇮🇹

Pavia, Italy

Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155

🇮🇹

Roma, Italy

Samsung Medical Center

🇰🇷

Seoul, Gangnam-gu, Korea, Republic of

Seoul National University Hospital

🇰🇷

Seoul, Jongno-gu, Korea, Republic of

Gachon University Hospital Gil Medical Center

🇰🇷

Incheon, Namdong-gu, Korea, Republic of

Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera

🇲🇽

Mexico, Distrito Federal, Mexico

Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

🇲🇽

Mexico, Distrito Federal, Mexico

CICUM San Miguel

🇲🇽

Guadalajara, Jalisco, Mexico

Unidad de Investigacion Clinica en Medicina, S.C.

🇲🇽

Monterrey, N.l., Mexico

VU Medisch Centrum, De Boelelaan 1117

🇳🇱

Amsterdam, Netherlands

Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a

🇵🇱

Bialystok, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80

🇵🇱

Krakow, Poland

NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18

🇵🇱

Otwock, Poland

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2

🇵🇱

Poznan, Poland

Premium Clinic Wrocław CM, Podwale 83/17

🇵🇱

Wroclaw, Poland

Hospital Garcia de Orta, E.P.E

🇵🇹

Almada, Portugal

Centro Hospitalar e Universitário de Coimbra, E.P.E.

🇵🇹

Coimbra, Portugal

Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente

🇵🇹

Lisboa, Portugal

Centro Hospitalar de Santo António E.P.E.

🇵🇹

Porto, Portugal

Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258

🇷🇴

Bucharest, Romania

Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5

🇷🇴

Bucuresti, Romania

Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21

🇷🇴

Cluj-Napoca, Romania

Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13

🇷🇴

Timisoara, Romania

Clinical Center of Serbia, Koste Todorovica 8

🇷🇸

Belgrade, Serbia

Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology

🇷🇸

Belgrade, Serbia

Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4

🇷🇸

Sremska Kamenica, Serbia

National University Hospital

🇸🇬

Singapore, Singapore

National Heart Centre

🇸🇬

Singapore, Singapore

Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia

🇪🇸

Barcelona, Spain

Hospital Clinic de Barcelona, C/ Villarroel, 170

🇪🇸

Barcelona, Spain

Hospital Universitario 12 de Octubre

🇪🇸

Madrid, Spain

Hospoital Universitari i Politecnic La Fe

🇪🇸

Valencia, Spain

Sahlgrenska Universitetssjukhuset

🇸🇪

Göteborg, Sweden

Linköping Universitetssjukhuset

🇸🇪

Linköping, Sweden

Norrlands Universitetssjukhus, Hjärtcentrum

🇸🇪

Umeå, Sweden

National Cheng Kung University Hospital

🇨🇳

Tainan, Taiwan

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

Osmangazi Uni Medical Faculty

🇹🇷

Eskişehir, Odunpazari, Turkey

Balcalı, Çukurova Üniversitesi Kardiyoloji ABD

🇹🇷

Adana, Saricam, Turkey

Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü

🇹🇷

Mersin, Yenisehir, Turkey

Gazi University Medical Faculty Hospital

🇹🇷

Ankara, Turkey

Uludag Universitesi Tip Fakültesi, Gorukle Kampusu

🇹🇷

Bursa, Turkey

Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10

🇹🇷

Istanbul, Turkey

Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova

🇹🇷

Izmir, Turkey

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, Ukraine

SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.

🇺🇦

Kyiv, Ukraine

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, Ukraine

Royal Free London NHS Foundation Trust, Pond Street

🇬🇧

London, Greater London, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital

🇬🇧

Newcastle upon Tyne, Tyne & Wear, United Kingdom

Golden Jubilee National Hospital

🇬🇧

Glasgow, West Dunbartonshire, United Kingdom

Royal Brompton Hospital

🇬🇧

London, United Kingdom

Imperial College Healthcare NHS Trust

🇬🇧

London, United Kingdom

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