MedPath

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension

Phase 3
Active, not recruiting
Conditions
Pulmonary Arterial Hypertension
Interventions
Registration Number
NCT04273945
Lead Sponsor
Actelion
Brief Summary

The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
935
Inclusion Criteria
  • Target population: greater than or equal to (>=) 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age
  • Target population: Symptomatic Pulmonary Arterial Hypertension (PAH) in World Health Organization Functional Class (WHO FC) II, III, or IV
  • Target population: PAH subtype falling in one of the below classifications: Idiopathic; Heritable; Drug- or toxin-induced; Related to: Connective tissue disease, HIV infection, Portal hypertension, and Congenital heart disease with small/coincidental cardiac defect with systemic-to-pulmonary shunt (for example atrial septal defect, ventricular septal defect, patent ductus arteriosus, atrioventricular septal defect) which does not account for the elevated pulmonary vascular resistance (PVR) or persistent PAH documented by an Right heart catheterization (RHC) >= 1 year after simple systemic-to pulmonary shunt repair
  • PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to screening: Mean pulmonary artery pressure (mPAP) greater than (>) 20 millimeters of mercury (mm Hg), and; Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) less than or equal to (<=) 15 mm Hg, and PVR >= 3 Wood Units (that is, >= 240 dyn*sec/cm^5)
  • Able to perform the 6-minute walking test (6MWT) with a minimum distance of 50 meters (m) and maximum distance of 440m at screening. Participants able to walk more than 440m at screening are eligible if they are in WHO FC III or IV and n-terminal prohormone of brain natriuretic peptide or n-terminal pro B-type natriuretic peptide (NT-proBNP) level is >=300 nanograms per liter (ng/L) at screening, based on central laboratory results
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Exclusion Criteria
  • Known presence of three or more of the following risk factors for heart failure with preserved ejection fraction at screening, based on records that confirm documented medical history: Body mass index (BMI) > 30 kilograms per meter square (kg/m^2), Diabetes mellitus of any type, Essential hypertension (even if well controlled); Coronary artery disease, that is, any of the following: history of stable angina, or known more than 50 percent (%) stenosis in a coronary artery, or history of myocardial infarction, or history of or planned coronary artery bypass grafting and/or coronary artery stenting
  • Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1 second [FEV1] / forced vital capacity [FVC] < 70%; and FEV1 < 60% of predicted after bronchodilator administration) ) in participants with a known or suspected history of significant lung disease as documented by a spirometry test performed within 1 year prior to screening
  • Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based on records that confirm documented medical history
  • Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5*upper limit of normal (ULN) at screening
  • Hemoglobin < 100 gram per liter (g/L) (< 10 gram per deciliter [g/dL]) at screening
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Macitentan 10 milligrams (mg) + PlaceboMacitentan 75 mgRun-in period:Participants who are either endothelin receptor antagonist (ERA)-naïve or who are receiving daily dose of macitentan or ambrisentan less (\<) 10 milligrams (mg), or daily dose of bosentan \<250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated participants will bypass run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.Double-blind Treatment (DBT) Period:Participants will receive macitentan 10 mg orally up to End of DBT.To maintain blind, participants will receive macitentan 37.5 mg-matching placebo for 4 weeks and macitentan 75 mg-matching placebo thereafter up to DBT.Treatment Extension Period:After EDBT, participants will receive macitentan 37.5 mg once a day (qd) orally for 4 weeks, prior to receiving open-label macitentan 75 mg qd orally for 2 years. To maintain blind, participants will receive macitentan 75 mg-matching placebo during 4-week uptitration.
Macitentan 10 milligrams (mg) + PlaceboMacitentan 10 mgRun-in period:Participants who are either endothelin receptor antagonist (ERA)-naïve or who are receiving daily dose of macitentan or ambrisentan less (\<) 10 milligrams (mg), or daily dose of bosentan \<250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated participants will bypass run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.Double-blind Treatment (DBT) Period:Participants will receive macitentan 10 mg orally up to End of DBT.To maintain blind, participants will receive macitentan 37.5 mg-matching placebo for 4 weeks and macitentan 75 mg-matching placebo thereafter up to DBT.Treatment Extension Period:After EDBT, participants will receive macitentan 37.5 mg once a day (qd) orally for 4 weeks, prior to receiving open-label macitentan 75 mg qd orally for 2 years. To maintain blind, participants will receive macitentan 75 mg-matching placebo during 4-week uptitration.
Macitentan 10 milligrams (mg) + PlaceboMacitentan 37.5 mgRun-in period:Participants who are either endothelin receptor antagonist (ERA)-naïve or who are receiving daily dose of macitentan or ambrisentan less (\<) 10 milligrams (mg), or daily dose of bosentan \<250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated participants will bypass run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.Double-blind Treatment (DBT) Period:Participants will receive macitentan 10 mg orally up to End of DBT.To maintain blind, participants will receive macitentan 37.5 mg-matching placebo for 4 weeks and macitentan 75 mg-matching placebo thereafter up to DBT.Treatment Extension Period:After EDBT, participants will receive macitentan 37.5 mg once a day (qd) orally for 4 weeks, prior to receiving open-label macitentan 75 mg qd orally for 2 years. To maintain blind, participants will receive macitentan 75 mg-matching placebo during 4-week uptitration.
Macitentan 75 mg + PlaceboMacitentan 37.5 mgRun-in period:Participants who are either ERA-naive or who are receiving a daily dose of macitentan or ambrisentan \<10 mg, or a daily dose of bosentan \<250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated patients will bypass the run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.DBT Period: participants will receive macitentan 37.5 mg orally for 4 weeks and macitentan 75 mg thereafter up to End of DBT. To maintain the blind, participants will receive macitentan 10 mg-matching placebo up to End of DBT.Treatment Extension Period: After EDBT, participants will continue to receive macitentan 75 mg orally for 2 years. To maintain the blind, participants will receive macitentan 37.5 mg-matching placebo during the 4-week up-titration period.
Macitentan 75 mg + PlaceboMacitentan 75 mgRun-in period:Participants who are either ERA-naive or who are receiving a daily dose of macitentan or ambrisentan \<10 mg, or a daily dose of bosentan \<250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated patients will bypass the run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.DBT Period: participants will receive macitentan 37.5 mg orally for 4 weeks and macitentan 75 mg thereafter up to End of DBT. To maintain the blind, participants will receive macitentan 10 mg-matching placebo up to End of DBT.Treatment Extension Period: After EDBT, participants will continue to receive macitentan 75 mg orally for 2 years. To maintain the blind, participants will receive macitentan 37.5 mg-matching placebo during the 4-week up-titration period.
Macitentan 75 mg + PlaceboPlaceboRun-in period:Participants who are either ERA-naive or who are receiving a daily dose of macitentan or ambrisentan \<10 mg, or a daily dose of bosentan \<250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated patients will bypass the run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.DBT Period: participants will receive macitentan 37.5 mg orally for 4 weeks and macitentan 75 mg thereafter up to End of DBT. To maintain the blind, participants will receive macitentan 10 mg-matching placebo up to End of DBT.Treatment Extension Period: After EDBT, participants will continue to receive macitentan 75 mg orally for 2 years. To maintain the blind, participants will receive macitentan 37.5 mg-matching placebo during the 4-week up-titration period.
Macitentan 10 milligrams (mg) + PlaceboPlaceboRun-in period:Participants who are either endothelin receptor antagonist (ERA)-naïve or who are receiving daily dose of macitentan or ambrisentan less (\<) 10 milligrams (mg), or daily dose of bosentan \<250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated participants will bypass run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.Double-blind Treatment (DBT) Period:Participants will receive macitentan 10 mg orally up to End of DBT.To maintain blind, participants will receive macitentan 37.5 mg-matching placebo for 4 weeks and macitentan 75 mg-matching placebo thereafter up to DBT.Treatment Extension Period:After EDBT, participants will receive macitentan 37.5 mg once a day (qd) orally for 4 weeks, prior to receiving open-label macitentan 75 mg qd orally for 2 years. To maintain blind, participants will receive macitentan 75 mg-matching placebo during 4-week uptitration.
Macitentan 75 mg + PlaceboMacitentan 10 mgRun-in period:Participants who are either ERA-naive or who are receiving a daily dose of macitentan or ambrisentan \<10 mg, or a daily dose of bosentan \<250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated patients will bypass the run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.DBT Period: participants will receive macitentan 37.5 mg orally for 4 weeks and macitentan 75 mg thereafter up to End of DBT. To maintain the blind, participants will receive macitentan 10 mg-matching placebo up to End of DBT.Treatment Extension Period: After EDBT, participants will continue to receive macitentan 75 mg orally for 2 years. To maintain the blind, participants will receive macitentan 37.5 mg-matching placebo during the 4-week up-titration period.
Primary Outcome Measures
NameTimeMethod
Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) EventsUp to 4 years

Time to first CEC-adjudicated M/M event on-treatment (ie.,up to 7 days after last dose of DB study intervention) is defined as time from randomization to first of following events: All-cause death, including death caused by on-treatment adverse event that occur within 4 weeks of study DB treatment discontinuation;non-planned Pulmonary Arterial Hypertension(PAH)-related hospitalization(including for worsening of PAH, atrial septostomy, lung transplantation with or without heart transplantation, or initiation of parenteral prostacyclins);PAH-related disease progression, defined as worsening of World Health Organization(WHO) Functional Class(FC) from baseline or deterioration by at least 15% in exercise capacity, as measured by 6-minute walk distance(6MWD), from baseline and confirmed by second 6MWD test performed on different day within 2 week of initial test or appearance or worsening of signs or symptoms of right-sided heart failure that require initiation of intravenous diuretics.

Secondary Outcome Measures
NameTimeMethod
Double-blind Treatment Period: Change From Baseline to Week 24 in 6MWDBaseline up to Week 24

The 6MWT is a non-encouraged test performed to quantify exercise tolerance and capacity. This standardized test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.

Double-blind Treatment Period: Number of Participants with CEC-adjudicated Death due to PAH and/or Hospitalizations for PAH (First and Recurrent) Events on-treatmentUp to 4 years

Number of Participants with CEC-adjudicated death or hospitalization due to PAH will be reported.

Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiopulmonary Symptom Domain ScoreBaseline up to Week 24

The Cardiopulmonary Symptoms domain consists of 6 items reported on a 5-point Likert scale (from 0 to 4). The value 0 means "no symptom" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH symptoms and impact questionnaire (PAH-SYMPACT) is completed daily for a 7-day period. The recall period of symptom items is the last 24 hours. An average Cardiopulmonary Symptoms domain score is determined based on the daily scores of the 6 items.

Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiovascular Symptom Domain ScoreBaseline up to Week 24

The Cardiovascular Symptoms domain consists of 5 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "no symptoms" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH-SYMPACT is completed daily for a 7 day period. The recall period of symptom items is the last 24 hours. An average cardiovascular symptoms domain score is determined based on the daily scores of the 5 items.

Double-blind Treatment Period: Time to Death Occurring Between Randomization and End of Double-blind Treatment (EDBT)Up to 4 years

Time to death occurring between randomization and EDBT will be reported.

Treatment Extension Period: Time to Death Occurring Between Randomization and End of Study (EOS)Up to 6 years

Time to death occurring between randomization and EOS will be reported.

Trial Locations

Locations (273)

Uniwersytecki Szpital Kliniczny w Bialymstoku

🇵🇱

Bialystok, Poland

SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca

🇵🇱

Katowice, Poland

Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn

🇵🇱

Krakow, Poland

Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo Rozwojowy

🇵🇱

Wroclaw, Poland

Mayo Clinic

🇺🇸

Phoenix, Arizona, United States

Arizona Pulmonary Specialists, Ltd

🇺🇸

Scottsdale, Arizona, United States

Scripps Memorial Hospital

🇺🇸

La Jolla, California, United States

USC Keck

🇺🇸

Los Angeles, California, United States

Jeffrey S. Sager, MD Medical Corporation

🇺🇸

Santa Barbara, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

🇺🇸

Torrance, California, United States

National Jewish Health

🇺🇸

Denver, Colorado, United States

Cleveland Clinic

🇺🇸

Weston, Florida, United States

Piedmont Healthcare

🇺🇸

Atlanta, Georgia, United States

Northside Hospital

🇺🇸

Atlanta, Georgia, United States

Advocate Christ Medical Center

🇺🇸

Oak Lawn, Illinois, United States

Indiana University

🇺🇸

Indianapolis, Indiana, United States

St. Vincent Medical Group, Inc.

🇺🇸

Indianapolis, Indiana, United States

University Of Iowa - Hospitals & Clinics

🇺🇸

Iowa City, Iowa, United States

Norton Pulmonary Specialists

🇺🇸

Louisville, Kentucky, United States

Louisiana State University

🇺🇸

New Orleans, Louisiana, United States

University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

Troy Beaumont

🇺🇸

Troy, Michigan, United States

Washington University School Of Medicine

🇺🇸

Saint Louis, Missouri, United States

Saint Louis University Academic Pavillion

🇺🇸

Saint Louis, Missouri, United States

University of Nebraska Medical Center

🇺🇸

Omaha, Nebraska, United States

Reno Heart Institute

🇺🇸

Reno, Nevada, United States

Winthrop University Hospital

🇺🇸

Mineola, New York, United States

Mount Sinai

🇺🇸

New York, New York, United States

Columbia University

🇺🇸

New York, New York, United States

Stony Brook University Medical Center

🇺🇸

Stony Brook, New York, United States

Duke

🇺🇸

Durham, North Carolina, United States

Lindner Clinical Trial Center/Christ Hospital

🇺🇸

Cincinnati, Ohio, United States

Integris Baptist Office

🇺🇸

Oklahoma City, Oklahoma, United States

The Oregon Clinic

🇺🇸

Portland, Oregon, United States

Oregon Pulmonary Clinic

🇺🇸

Portland, Oregon, United States

Oregon Health And Science University

🇺🇸

Portland, Oregon, United States

University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

Allegheny General Hospital of Research

🇺🇸

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

🇺🇸

Wynnewood, Pennsylvania, United States

AnMed Health

🇺🇸

Anderson, South Carolina, United States

UT Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

Baylor College of Medicine (BCM) - Baylor Heart Clinic

🇺🇸

Houston, Texas, United States

Baylor Scott White - Plano

🇺🇸

Plano, Texas, United States

San Antonio Methodist TX Transplant Physicians Group

🇺🇸

San Antonio, Texas, United States

The Robert Larner, M.D. College of Medicine at The University of Vermont

🇺🇸

Burlington, Vermont, United States

University of Wisconsin Hospital and Clinics

🇺🇸

Madison, Wisconsin, United States

Medical College Of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

Sanatorio de la Trinidad Mitre

🇦🇷

Buenos Aires, Argentina

Sanatorio Guemes

🇦🇷

C.a.b.a., Argentina

Hospital Italiano de Buenos Aires

🇦🇷

Caba, Argentina

Sanatorio Ramon Cereijo

🇦🇷

Caba, Argentina

Centro Médico Dra. De Salvo

🇦🇷

Caba, Argentina

Instituto de Cardiologia de Corrientes

🇦🇷

Corrientes, Argentina

Instituto Medico de La Fundacion Estudios Clinicos

🇦🇷

Rosario, Argentina

Instituto Cardiovascular de Rosario

🇦🇷

Rosario, Argentina

Flinders Medical Centre

🇦🇺

Bedford Park, Australia

Royal Prince Alfred Hospital

🇦🇺

Camperdown, Australia

The Prince Charles Hospital

🇦🇺

Chermside, Australia

St Vincent's hospital

🇦🇺

Darlinghurst, Australia

Royal Hobart Hospital

🇦🇺

Hobart, Australia

Fiona Stanley Hospital

🇦🇺

Murdoch, Australia

Westmead Hospital

🇦🇺

Westmead, Australia

LKH-Univ. Klinikum Graz

🇦🇹

Graz, Austria

Ordensklinikum Linz GmbH Elisabethinen

🇦🇹

Linz, Austria

Medical University Vienna

🇦🇹

Vienna, Austria

The Republican Scientific-Practical Center ''Cardiology''

🇧🇾

Minsk, Belarus

Minsk Regional Clinical Hospital

🇧🇾

Minsk, Belarus

ULB Hôpital Erasme

🇧🇪

Brussels, Belgium

UZ Leuven

🇧🇪

Leuven, Belgium

Universidade Federal De Minas Gerais - Hospital das Clínicas

🇧🇷

Belo Horizonte, Brazil

Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

🇧🇷

Belo Horizonte, Brazil

Empresa Brasileira de Servicos Hospitalares-EBSERH-Hospital Universitario de Brasilia

🇧🇷

Brasilia, Brazil

Sociedade Hospitalar Angelina Caron - Hospital Angelina Caron

🇧🇷

Campina Grande do Sul, Brazil

Ceti - Centro de Estudos Em Terapias Inovadoras

🇧🇷

Curitiba, Brazil

Ynova Pesquisa Clinica

🇧🇷

Florianopolis, Brazil

Universidade Federal de Goias - Hospital das Clinicas da UFG

🇧🇷

Goiania, Brazil

Hospital das Clinicas de Porto Alegre

🇧🇷

Porto Alegre, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

🇧🇷

Porto Alegre, Brazil

Instituto de Medicina Integral Professor Fernando Figueira

🇧🇷

Recife, Brazil

Fundacao do ABC Centro Universitario FMABC

🇧🇷

Santo Andre, Brazil

Secretaria de Estado da Saude Instituto Dante Pazzanese de Cardiologia

🇧🇷

Sao Paulo, Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP

🇧🇷

Sao Paulo, Brazil

Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead

🇧🇬

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

🇧🇬

Sofia, Bulgaria

St. Joseph's Health Centre

🇨🇦

Hamilton, Ontario, Canada

University of Ottawa Heart Institute

🇨🇦

Ottawa, Ontario, Canada

University Health Network - Toronto General Hospital

🇨🇦

Toronto, Ontario, Canada

Jewish General Hospital

🇨🇦

Montreal, Quebec, Canada

Beijing Chaoyang Hospital

🇨🇳

Beijing, China

Beijing Anzhen Hospital

🇨🇳

Beijing, China

Peking Union Medical College Hospital

🇨🇳

Beijing, China

The Second Xiangya Hospital of Central South Hospital

🇨🇳

Changsha, China

West China Hospital Sichuan University

🇨🇳

Chengdu, China

The First Affiliated Hospital of Chongqing Medical University

🇨🇳

Chongqing, China

The First Affiliated Hospital of Guangzhou Medical University

🇨🇳

Guangzhou, China

Shanghai Pulmonary Hospital

🇨🇳

Shanghai, China

Renji Hospital

🇨🇳

Shanghai, China

Zhongshan Hospital Fudan University

🇨🇳

Shanghai, China

The General Hospital of Northern Theater Command

🇨🇳

Shenyang, China

Shengjing Hospital Of China Medical University

🇨🇳

Shenyang, China

Tianjin Medical University General Hospital

🇨🇳

Tianjin, China

The First Affiliated Hospital of Xian Jiaotong University

🇨🇳

Xi'An, China

Fundacion Neumologica Colombiana

🇨🇴

Bogota, Colombia

Fundacion Cardiovascular de Colombia

🇨🇴

Bucaramanga - Piedecuesta - Valle De Menzuli, Colombia

Clínica Imbanaco S.A.S.

🇨🇴

Cali, Colombia

Centro Cardiovascular Colombiano Clínica Santa María

🇨🇴

Medellin, Colombia

Hospital Universidad del Norte

🇨🇴

Soledad, Colombia

General University Hospital II.department of Internal Medicine-cardiology and angiology

🇨🇿

Praha 2, Czechia

Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B

🇩🇰

Arhus, Denmark

CHU de Brest - Hopital de la Cavale Blanche

🇫🇷

Brest, France

Hôpital Côte de Nacre

🇫🇷

Caen Cedex, France

Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud

🇫🇷

Le Kremlin Bicêtre cedex, France

CHRU de Lille Hopital Claude Huriez

🇫🇷

Lille Cedex, France

Aphm - Hopital Nord

🇫🇷

Marseille Cedex 20, France

Centre Hospitalier Universitaire - de Nice - Hopital Pasteur

🇫🇷

Nice, France

CHU Saint Etienne Hopital Nord

🇫🇷

St Priest en Jarez Cedex, France

Hopital Larrey CHU de Toulouse

🇫🇷

Toulouse Cedex 9, France

Ruhr Universitat Bochum Diabeteszentrum

🇩🇪

Bad Oeynhausen, Germany

Medizinische Hochschule Hannover

🇩🇪

Hannover, Germany

Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMU

🇩🇪

München, Germany

Universitaetsklinikum Regensburg

🇩🇪

Regensburg, Germany

University Hospital of Alexandroupolis

🇬🇷

Alexandroupoli, Greece

Alexandra General Hospital of Athens

🇬🇷

Athens, Greece

University Hospital Of Larissa

🇬🇷

Larisa, Greece

Ahepa University General Hospital of Thessaloniki

🇬🇷

Thessaloniki, Greece

Semmelweis Egyetem,Pulmonológiai Klinika

🇭🇺

Budapest, Hungary

Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet Felnott kardiologiai osztaly

🇭🇺

Budapest, Hungary

Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

🇭🇺

Pecs, Hungary

Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő

🇭🇺

Szeged, Hungary

NHL Medical College (SVP Hospital IMSR)

🇮🇳

Ahmedabad, India

Cims Hospital

🇮🇳

Ahmedabad, India

Narayana Hrudayalaya Limited

🇮🇳

Bangalore, India

SRM Medical College Hospital & Research Centre

🇮🇳

Chengalpetu, India

Govindaswamy Kuppuswamy Naidu Memorial Hospital

🇮🇳

Coimbatore, India

HealthWorld Hospitals

🇮🇳

Durgapur, India

Care Hospitals

🇮🇳

Hyderbad, India

Rabindranath Tagore International Institute of Cardiac Sciences

🇮🇳

Kolkata, India

GB Pant Institute of Post Graduate Medical Education & Research

🇮🇳

New Delhi, India

Sir Ganga Ram Hospital

🇮🇳

New Delhi, India

Jawaharlal Institute of Postgraduate Medical Education and Research

🇮🇳

Pondicherry, India

B.D. Mehta Mahavir Heart Institute

🇮🇳

Surat, India

Carmel Medical Center

🇮🇱

Haifa, Israel

Shaare Zedek Medical Center

🇮🇱

Jerusalem, Israel

Kaplan Medical Center

🇮🇱

Rehovot, Israel

The Chaim Sheba Medical Center

🇮🇱

Tel-Hashomer, Israel

Yitzhak Shamir Medical Center

🇮🇱

Zerifin, Israel

ASST Grande Ospedale Metropolitano Niguarda

🇮🇹

Milano, Italy

AOU Di Modena Policlinico Di Modena

🇮🇹

Modena, Italy

Ospedale San Francesco

🇮🇹

Nuoro, Italy

Fondazione IRCCS Policlinico San Matteo

🇮🇹

Pavia, Italy

Fondazione Toscana Gabriele Monasterio CNR

🇮🇹

Pisa, Italy

Policlinico Gemelli Universita Cattolica

🇮🇹

Roma, Italy

The University of Tokyo Hospital

🇯🇵

Bunkyo, Japan

Kyushu University Hospital

🇯🇵

Fukuoka, Japan

Kure Kyosai Hospital

🇯🇵

Hiroshima, Japan

Kagoshima University Hospital

🇯🇵

Kagoshima City, Japan

St Marianna University Hospital

🇯🇵

Kanagawa, Japan

Kanazawa University Hospital

🇯🇵

Kanazawa, Japan

Kobe University Hospital

🇯🇵

Kobe, Japan

Kurume University Hospital

🇯🇵

Kurume, Japan

University Hospital Kyoto Prefectural University of Medicine

🇯🇵

Kyoto, Japan

Kyoto University Hospital

🇯🇵

Kyoto, Japan

Shinshu University Hospital

🇯🇵

Matsumoto, Japan

Nagasaki University Hospital

🇯🇵

Nagasaki-shi, Japan

Nagoya University Hospital

🇯🇵

Nagoya, Japan

Nagoya City University Hospital

🇯🇵

Nagoya, Japan

Niigata University Medical And Dental Hospital

🇯🇵

Niigata, Japan

Okayama University Hospital

🇯🇵

Okayama, Japan

National Hospital Organization Okayama Medical Center

🇯🇵

Okayama, Japan

Hokkaido University Hospital

🇯🇵

Sapporo-shi, Japan

Sapporo Medical University Hospital

🇯🇵

Sapporo, Japan

National Cerebral and Cardiovascular Center

🇯🇵

Suita-Shi, Japan

Juntendo University Hospital

🇯🇵

Tokyo, Japan

Fujita Health University Hospital

🇯🇵

Toyoake, Japan

University of Tsukuba Hospital

🇯🇵

Tsukuba City, Japan

Severance Hospital Yonsei University Health System

🇰🇷

Seoul, Korea, Republic of

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Hospital Pulau Pinang

🇲🇾

George Town, Malaysia

Hospital Serdang

🇲🇾

Kajang, Malaysia

Sarawak Heart Center

🇲🇾

Kota Samarahan, Malaysia

Institut Jantung Negara (National Heart Institute)

🇲🇾

Kuala Lumpur, Malaysia

Instituto Nacional de Cardiologia Dr. Ignacio Chavez

🇲🇽

Ciudad De México, Mexico

Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez

🇲🇽

Guadalajara, Mexico

Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas

🇲🇽

Mexico, Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

🇲🇽

Monterrey, Mexico

Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)

🇲🇽

Monterrey, Mexico

Centro de Investigacion Clinica Chapultepec

🇲🇽

Morelia, Mexico

VUMC Amsterdam

🇳🇱

Amsterdam, Netherlands

St. Antonius Ziekenhuis Nieuwegein

🇳🇱

Nieuwegein, Netherlands

Radboud Umcn

🇳🇱

Nijmegen, Netherlands

Erasmus MC

🇳🇱

Rotterdam, Netherlands

Akershus Universitetssykehus

🇳🇴

Nordbyhagen, Norway

Oslo University Hospital

🇳🇴

Oslo, Norway

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii

🇵🇱

Bydgoszcz, Poland

Uniwersyteckie Centrum Kliniczne

🇵🇱

Gdansk, Poland

Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie

🇵🇱

Szczecin, Poland

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

🇵🇱

Warszawa, Poland

Uls Coimbra - Hosp. Univ. Coimbra

🇵🇹

Coimbra, Portugal

Uls Santa Maria - Hosp. Pulido Valente

🇵🇹

Lisboa, Portugal

Uls Sao Jose - Hosp. Santa Marta

🇵🇹

Lisbon, Portugal

Altay Regional Cardiological Dispensary

🇷🇺

Barnaul, Russian Federation

Chelyabinsk Regional Clinical Hospital

🇷🇺

Chelyabinsk, Russian Federation

State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'

🇷🇺

Kazan, Russian Federation

Scientific and Research Institution of Cardiovascular Diseases Complex Problems

🇷🇺

Kemerovo, Russian Federation

Moscow City Clinical Hospital No.51

🇷🇺

Moscow, Russian Federation

National Medical Research Center of Cardiology of MoH of Russian Federation

🇷🇺

Moscow, Russian Federation

National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation

🇷🇺

Saint-Petersburg, Russian Federation

Samara Regional Clinical Cardiological Dispensary

🇷🇺

Samara, Russian Federation

State Autonomous Healthcare Institution of Tyumen Region 'Scientific and Practical Medical Center'

🇷🇺

Tumen, Russian Federation

Volgograd Regional Clinical Cardiology Center

🇷🇺

Volgograd, Russian Federation

King Faisal Specialist Hospital & Research Center

🇸🇦

Riyadh, Saudi Arabia

King Fahad Medical City

🇸🇦

Riyadh, Saudi Arabia

University Clinical Center of Serbia

🇷🇸

Belgrade, Serbia

Institute for Pulmonary Disease of Vojvodina

🇷🇸

Sremska Kamenica, Serbia

National University Heart Centre, Singapore

🇸🇬

Singapore, Singapore

National Heart Centre (NHC) Singapore

🇸🇬

Singapore, Singapore

Narodny ustav srdcovych a cievnych chorob

🇸🇰

Bratislava, Slovakia

The Eastern Slovakia Institute of Cardiovascular Diseases

🇸🇰

Kosice, Slovakia

Milpark Hospital

🇿🇦

Johannesburg, South Africa

Dr Kalla

🇿🇦

Lenasia, South Africa

Hosp Univ Vall D Hebron

🇪🇸

Barcelona, Spain

Hosp. Del Mar

🇪🇸

Barcelona, Spain

Hosp. Univ. 12 de Octubre

🇪🇸

Madrid, Spain

Hosp. Univ. La Paz

🇪🇸

Madrid, Spain

Hosp. Univ. Pta. de Hierro Majadahonda

🇪🇸

Madrid, Spain

Hosp. Costa Del Sol

🇪🇸

Malaga, Spain

Hosp Clinico Univ de Salamanca

🇪🇸

Salamanca, Spain

Sahlgrenska Universitetsjukhuset

🇸🇪

Goteborg, Sweden

Skanes universitetssjukhus

🇸🇪

Lund, Sweden

National Cheng Kung University Hospital

🇨🇳

Tainan, Taiwan

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

Mackay Memorial Hospital

🇨🇳

Taipei, Taiwan

Taipei Veterans General Hospital

🇨🇳

Taipei, Taiwan

Phramongkutklao Hospital and Medical College

🇹🇭

Bangkok, Thailand

Ramathibodi Hospital Mahidol University

🇹🇭

Bangkok, Thailand

Siriraj Hospital Mahidol University

🇹🇭

Bangkok, Thailand

Maharaj Nakorn Chiang Mai hospital Faculty of Medicine

🇹🇭

Chiang Mai, Thailand

Srinagarind Hospital, Khon Kaen University

🇹🇭

Khon Kaen, Thailand

Songklanagarind hospital

🇹🇭

Songkhla, Thailand

Adana City Hospital

🇹🇷

Adana, Turkey

Cukurova University Medical Faculty

🇹🇷

Adana, Turkey

Ankara Etlik Speciality Hospital

🇹🇷

Ankara, Turkey

Hacettepe University Medical Faculty

🇹🇷

Ankara, Turkey

Gazi University Medical Faculty

🇹🇷

Ankara, Turkey

Ankara Bilkent Sehir Hastanesi

🇹🇷

Ankara, Turkey

Akdeniz University Medical Faculty

🇹🇷

Antalya, Turkey

Bursa Yuksek Ihtisas Training and Research Hospital

🇹🇷

Bursa, Turkey

Pamukkale University Medical Faculty

🇹🇷

Denizli, Turkey

Siyami Ersek Training and Research Hospital

🇹🇷

Istanbul, Turkey

Marmara University Medical Faculty

🇹🇷

Istanbul, Turkey

Ege University Medical Faculty

🇹🇷

Izmir, Turkey

Tepecik Training and Research Hospital

🇹🇷

Izmir, Turkey

Dokuz Eylul University Medical Faculty

🇹🇷

Izmir, Turkey

Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi

🇹🇷

Kartal Istanbul, Turkey

Mersin University Medical Faculty

🇹🇷

Mersin, Turkey

CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'

🇺🇦

Cherkassy, Ukraine

Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

🇺🇦

Cherkasy, Ukraine

MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'

🇺🇦

Dnipro, Ukraine

CNE' City Clinical Hospital #8' of Kharkiv City Council

🇺🇦

Kharkiv, Ukraine

SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

🇺🇦

Kyiv, Ukraine

State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

🇺🇦

Kyiv, Ukraine

Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

🇺🇦

Lviv, Ukraine

Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council

🇺🇦

Ternopil, Ukraine

Royal Free Hospital

🇬🇧

London, United Kingdom

Freeman Hospital

🇬🇧

Newcastle Upon Tyne, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

🇬🇧

Sheffield, United Kingdom

Hanoi Medical University Hospital

🇻🇳

Hanoi, Vietnam

Cho Ray Hospital

🇻🇳

Ho Chi Minh, Vietnam

Tam Anh Hospital

🇻🇳

Ho Chi Minh, Vietnam

Tam Duc Heart Hospital

🇻🇳

Ho Chi Minh, Vietnam

University Medical Center Ho Chi Minh city

🇻🇳

Ho Chi Minh, Vietnam

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