Phase
Condition
Vascular Diseases
Williams Syndrome
Pulmonary Arterial Hypertension
Treatment
Background PAH Therapy
Sotatercept
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has documented diagnostic Right Heart Catheterization, with the diagnosis of WorldHealth Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of thefollowing subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAHassociated with connective tissue disease, PAH associated with simple, congenitalsystemic-to-pulmonary shunts at least 1 year following repair
Has symptomatic PAH classified as WHO Functional Class II or III
Exclusion
Exclusion Criteria:
Has a weight of <35 kg
Has a diagnosis of PH WHO Groups 2, 3, 4, or 5
Has a diagnosis of the following PAH Group 1 subtypes: HIV-associated PAH, PAHassociated with portal hypertension, Exclusion in PAH Group 1 should also includeschistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonarycapillary hemangiomatosis
Has uncontrolled systemic hypertension
Has a history of pneumonectomy
Has a history of known pericardial constriction
Has a history of restrictive cardiomyopathy
Has history of atrial septostomy (within 180 days prior to study start)
Has personal or family history of long QT syndrome
Has history of coronary artery disease (myocardial infarction, percutaneous coronaryintervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start)
Has a cerebrovascular accident (within 3 months prior to study start)
Has significant (>2+ regurgitation) mitral regurgitation or aortic regurgitationvalvular disease
Has untreated more than mild obstructive sleep apnea
Has known malignancy that is progressing or has required active treatment within thepast 5 years
Has recently started (within 12 months prior to study start) or has plans to startweight loss medication or enter a weight loss program during the study period
Has a previous (within 3 years) or planned (during the study) obesity treatment withsurgery or a weight-loss device
Study Design
Connect with a study center
Centro Medico Capital ( Site 0002)
La Plata, Buenos Aires B1904AAW
ArgentinaActive - Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)
Mar del plata, Buenos Aires B7600FZO
ArgentinaActive - Recruiting
Instituto Medico Rio Cuarto ( Site 0010)
Rio Cuarto, Cordoba X5800AEV
ArgentinaActive - Recruiting
Hospital Britanico de Buenos Aires ( Site 0004)
Caba, C1280AEB
ArgentinaActive - Recruiting
Instituto de Cardiologia Juana F. Cabral ( Site 0008)
Corrientes, W3400AMZ
ArgentinaActive - Recruiting
Hospital Provincial Jose Maria Cullen ( Site 0005)
Santa Fe, 3000
ArgentinaActive - Recruiting
Royal Prince Alfred Hospital ( Site 0103)
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
Westmead Hospital ( Site 0100)
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Wesley Research Institute ( Site 0101)
Auchenflower, Queensland 4066
AustraliaActive - Recruiting
The Alfred Hospital ( Site 0102)
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Peter Lougheed Centre ( Site 0203)
Calgary, Alberta T1Y 6J4
CanadaActive - Recruiting
IUCPQ ( Site 0208)
Quebec, G1V 4G5
CanadaActive - Recruiting
Guangdong Provincial People s Hospital ( Site 2000)
Guangzhou, Guangdong 510080
ChinaSite Not Available
The Second Xiangya Hospital of Central South University ( Site 2002)
Changsha, Hunan 410011
ChinaActive - Recruiting
Shanghai Pulmonary Hospital ( Site 2004)
Shanghai, Shanghai 200433
ChinaActive - Recruiting
Yan an Hospital of Kunming City ( Site 2011)
Kunming, Yunnan 650051
ChinaActive - Recruiting
Clinica Cardio VID ( Site 0307)
Medellín, Antioquia 050034
ColombiaActive - Recruiting
Oncomedica S.A. ( Site 0301)
Monteria, Cordoba 230002
ColombiaActive - Recruiting
Fundacion Santa Fe de Bogota ( Site 0302)
Bogota, Cundinamarca 110111
ColombiaActive - Recruiting
Clinica Colsanitas - Sede Reina Sofia ( Site 0303)
Bogota, Distrito Capital De Bogota 110111
ColombiaActive - Recruiting
Centro de Investigaciones Clinicas SAS ( Site 0306)
Cali, Valle Del Cauca 760036
ColombiaActive - Recruiting
Clínica Imbanaco S.A.S ( Site 0304)
Cali, Valle Del Cauca 760042
ColombiaActive - Recruiting
Centrum pro plicní hypertenzi VFN II. interni klinika VFN a 1. LF UK ( Site 0400)
Prague, Praha 2 128 08
CzechiaActive - Recruiting
CHU Bordeaux Haut-Leveque ( Site 0501)
Pessac, Aquitaine 33604
FranceActive - Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0500)
Marseille, Bouches-du-Rhone 13015
FranceActive - Recruiting
CHU Dijon Bourgogne ( Site 0502)
Dijon, Cote-d Or 2100
FranceActive - Recruiting
CHU de Rouen ( Site 0503)
Rouen, Haute-Normandie 76000
FranceActive - Recruiting
CHU GABRIEL MONTPIED ( Site 0504)
Clermont-Ferrand, Puy-de-Dome 63003
FranceActive - Recruiting
Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 0600)
Heidelberg, Baden-Wurttemberg 69126
GermanyActive - Recruiting
Klinikum der Universität München Großhadern ( Site 0611)
Munchen, Bayern 81377
GermanyActive - Recruiting
Medizinische Hochschule Hannover ( Site 0604)
Hannover, Niedersachsen 30625
GermanyActive - Recruiting
Universitätsklinikum Bonn ( Site 0608)
Bonn, Nordrhein-Westfalen 53127
GermanyActive - Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0609)
Berlin, 10117
GermanyActive - Recruiting
Universitaetsklinikum Hamburg-Eppendorf ( Site 0610)
Hamburg, 20246
GermanyActive - Recruiting
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 0704)
Szeged, Csongrad 6725
HungaryActive - Recruiting
Pécsi Tudományegyetem Klinikai Központ ( Site 0703)
Pécs, Pecs 7624
HungaryActive - Recruiting
Semmelweis Egyetem ( Site 0701)
Budapest, Pest 1083
HungaryActive - Recruiting
Gottsegen Gyorgy Orszagos Kardiologiai Intezet ( Site 0702)
Budapest, 1096
HungaryActive - Recruiting
Carmel Hospital ( Site 0803)
Haifa, 3436212
IsraelActive - Recruiting
Rambam Health Care Campus ( Site 0802)
Haifa, 3109601
IsraelActive - Recruiting
Rabin Medical Center ( Site 0805)
Petah-Tikva, 4941492
IsraelActive - Recruiting
Sheba Medical Center ( Site 0801)
Ramat Gan, 5265601
IsraelActive - Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905)
Bologna, Emilia-Romagna 40138
ItalyActive - Recruiting
AOU Policlinico Umberto I ( Site 0910)
Roma, Lazio 00161
ItalyActive - Recruiting
Ospedale San Martino ( Site 0901)
Genova, Liguria 16132
ItalyActive - Recruiting
ASST Grande Ospedale Metropolitano Niguarda ( Site 0900)
Milan, Lombardia 20162
ItalyActive - Recruiting
Fondazione IRCCS San Gerardo dei Tintori ( Site 0911)
Monza, Lombardia 20900
ItalyActive - Recruiting
A.O.U. Citta della Salute e della Scienza di Torino ( Site 0904)
Torino, Piemonte 10126
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Integrata ( Site 0908)
Verona, Veneto 37126
ItalyActive - Recruiting
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0902)
Milano, 20122
ItalyActive - Recruiting
Fondazione IRCCS Policlinico San Matteo ( Site 0909)
Pavia, 27100
ItalyActive - Recruiting
Fondazione G. Monasterio ( Site 0907)
Pisa, 56124
ItalyActive - Recruiting
Ospedale Civile SS Annunziata ( Site 0903)
Sassari, 07100
ItalyActive - Recruiting
Nagoya University Hospital ( Site 2102)
Nagoya, Aichi 466-8560
JapanActive - Recruiting
National Cerebral and Cardiovascular Center ( Site 2103)
Suita, Osaka 564-8565
JapanActive - Recruiting
The University of Tokyo Hospital ( Site 2101)
Bunkyo, Tokyo 113-8655
JapanActive - Recruiting
Kyorin University Hospital ( Site 2100)
Mitaka, Tokyo 181-8611
JapanSite Not Available
Kyushu University Hospital ( Site 2105)
Fukuoka, 812-8582
JapanActive - Recruiting
National Hospital Organization Okayama Medical Center ( Site 2104)
Okayama, 701-1192
JapanSite Not Available
Chonnam National University Hospital (CNUH) ( Site 1304)
Gwangju, Kwangju-Kwangyokshi 61469
Korea, Republic ofActive - Recruiting
Pusan National University Hospital ( Site 1305)
Busan, Pusan-Kwangyokshi 49241
Korea, Republic ofActive - Recruiting
Asan Medical Center ( Site 1303)
Seoul, 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center ( Site 1301)
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital ( Site 1302)
Seoul, 03080
Korea, Republic ofActive - Recruiting
Severance Hospital Yonsei University Health System ( Site 1300)
Seoul, 03722
Korea, Republic ofActive - Recruiting
Radboud University Medical Center ( Site 1001)
Nijmegen, Gelderland 6525 GA
NetherlandsActive - Recruiting
Sint Antonius Ziekenhuis ( Site 1000)
Nieuwegein, Utrecht 3435CM
NetherlandsActive - Recruiting
Krakowski Szpital Specjalistyczny im. św. Jana Pawła II ( Site 1100)
Krakow, Malopolskie 31-202
PolandActive - Recruiting
National Heart Centre Singapore ( Site 1201)
Singapore, Central Singapore 169609
SingaporeActive - Recruiting
National University Heart Centre, Singapore ( Site 1200)
Singapore, Central Singapore 119074
SingaporeActive - Recruiting
Hospital Universitari Son Espases ( Site 1412)
Palma, Baleares 07120
SpainActive - Recruiting
Hospital Marques de Valdecilla ( Site 1405)
Santander, Cantabria 39008
SpainActive - Recruiting
Hospital Clinic de Barcelona ( Site 1406)
Barcelona, Cataluna 08036
SpainActive - Recruiting
Hospital Vall D Hebron ( Site 1404)
Barcelona, 08035
SpainActive - Recruiting
Hospital General Universitario 12 de Octubre ( Site 1403)
Madrid, 28041
SpainActive - Recruiting
Hospital Ramon y Cajal ( Site 1401)
Madrid, 28034
SpainActive - Recruiting
Hospital Universitario La Paz ( Site 1410)
Madrid, 28046
SpainActive - Recruiting
Hospital Virgen del Rocio ( Site 1407)
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario de Toledo ( Site 1408)
Toledo, 45007
SpainActive - Recruiting
Kaohsiung Veterans General Hospital ( Site 1503)
Kaohsiung, 813414
TaiwanActive - Recruiting
National Cheng Kung University Hospital ( Site 1501)
Tainan, 70403
TaiwanActive - Recruiting
Taipei Veterans General Hospital ( Site 1502)
Taipei, 11217
TaiwanActive - Recruiting
Faculty of Medicine Siriraj Hospital ( Site 1600)
Bangkok, Krung Thep Maha Nakhon 10700
ThailandActive - Recruiting
Maharaj Nakorn Chiang Mai Hospital ( Site 1601)
Chiang Mai, 50200
ThailandActive - Recruiting
Papworth Hospital NHS Foundation Trust ( Site 1802)
Cambridge, Cambridgeshire CB23 3RE
United KingdomActive - Recruiting
Royal Papworth Hospital ( Site 1802)
Cambridge, Cambridgeshire CB2 0AY
United KingdomActive - Recruiting
Hammersmith Hospital ( Site 1801)
London, London, City Of W12 OHS
United KingdomActive - Recruiting
Royal Brompton Hospital ( Site 1804)
London, London, City Of SW3 6NP
United KingdomActive - Recruiting
Royal Free London NHS Foundation Trust ( Site 1803)
London, London, City Of NW3 2QG
United KingdomActive - Recruiting
Golden Jubilee National Hospital ( Site 1800)
Glasgow, West Dunbartonshire G81 4DY
United KingdomActive - Recruiting
Pulmonary Associates, PA ( Site 1903)
Phoenix, Arizona 85032
United StatesActive - Recruiting
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular
Aurora, Colorado 80045
United StatesActive - Recruiting
Indiana University Health Methodist Hospital ( Site 1905)
Indianapolis, Indiana 46202
United StatesActive - Recruiting
University of Kansas Medical Center ( Site 1928)
Kansas City, Kansas 66160
United StatesActive - Recruiting
Norton Pulmonary Specialists ( Site 1935)
Louisville, Kentucky 40202
United StatesActive - Recruiting
University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)
Albuquerque, New Mexico 87131
United StatesActive - Recruiting
University of Cincinnati Medical Center ( Site 1927)
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Ascension Seton Heart Specialty Care and Transplant Center ( Site 1918)
Austin, Texas 78705
United StatesActive - Recruiting
Froedtert Hospital & the Medical College of Wisconsin ( Site 1934)
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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