Phase
Condition
Pulmonary Arterial Hypertension
Circulation Disorders
Williams Syndrome
Treatment
Sotatercept
Background PAH Therapy
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
ArgentinaSite Not Available
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)
Mar del plata, Buenos Aires B7600FZO
ArgentinaSite Not Available
Instituto Medico Rio Cuarto ( Site 0010)
Rio Cuarto, Cordoba X5800AEV
ArgentinaSite Not Available
Hospital Britanico de Buenos Aires ( Site 0004)
Caba, C1280AEB
ArgentinaSite Not Available
Instituto de Cardiologia Juana F. Cabral ( Site 0008)
Corrientes, W3400AMZ
ArgentinaSite Not Available
Hospital Provincial Jose Maria Cullen ( Site 0005)
Santa Fe, 3000
ArgentinaSite Not Available
Royal Prince Alfred Hospital ( Site 0103)
Camperdown, New South Wales 2050
AustraliaSite Not Available
Westmead Hospital ( Site 0100)
Westmead, New South Wales 2145
AustraliaSite Not Available
Wesley Research Institute ( Site 0101)
Auchenflower, Queensland 4066
AustraliaSite Not Available
The Alfred Hospital ( Site 0102)
Melbourne, Victoria 3004
AustraliaSite Not Available
Peter Lougheed Centre ( Site 0203)
Calgary, Alberta T1Y 6J4
CanadaSite Not Available
IUCPQ ( Site 0208)
Quebec, G1V 4G5
CanadaSite Not Available
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
ChinaSite Not Available
Shanghai Pulmonary Hospital ( Site 2004)
Shanghai, Shanghai 200433
ChinaSite Not Available
Yan an Hospital of Kunming City ( Site 2011)
Kunming, Yunnan 650051
ChinaSite Not Available
Clinica Cardio VID ( Site 0307)
Medellín, Antioquia 050034
ColombiaSite Not Available
IMAT S.A.S ( Site 0301)
Monteria, Cordoba 230002
ColombiaSite Not Available
Oncomedica S.A. ( Site 0301)
Monteria, Cordoba 230002
ColombiaActive - Recruiting
Fundacion Santa Fe de Bogota ( Site 0302)
Bogota, Cundinamarca 110111
ColombiaSite Not Available
Clinica Colsanitas - Sede Reina Sofia ( Site 0303)
Bogota, Distrito Capital De Bogota 110111
ColombiaSite Not Available
Centro de Investigaciones Clinicas SAS ( Site 0306)
Cali, Valle Del Cauca 760036
ColombiaSite Not Available
Clínica Imbanaco S.A.S ( Site 0304)
Cali, Valle Del Cauca 760042
ColombiaSite Not Available
Centrum pro plicní hypertenzi VFN II. interni klinika VFN a 1. LF UK ( Site 0400)
Prague, Praha 2 128 08
CzechiaSite Not Available
CHU Bordeaux Haut-Leveque ( Site 0501)
Pessac, Aquitaine 33604
FranceSite Not Available
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0500)
Marseille, Bouches-du-Rhone 13015
FranceSite Not Available
CHU Dijon Bourgogne ( Site 0502)
Dijon, Cote-d Or 2100
FranceSite Not Available
CHU de Rouen ( Site 0503)
Rouen, Haute-Normandie 76000
FranceSite Not Available
CHU GABRIEL MONTPIED ( Site 0504)
Clermont-Ferrand, Puy-de-Dome 63003
FranceSite Not Available
Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 0600)
Heidelberg, Baden-Wurttemberg 69126
GermanySite Not Available
Klinikum der Universität München Großhadern ( Site 0611)
Munchen, Bayern 81377
GermanySite Not Available
Medizinische Hochschule Hannover ( Site 0604)
Hannover, Niedersachsen 30625
GermanySite Not Available
Universitätsklinikum Bonn ( Site 0608)
Bonn, Nordrhein-Westfalen 53127
GermanySite Not Available
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0609)
Berlin, 10117
GermanySite Not Available
Universitaetsklinikum Hamburg-Eppendorf ( Site 0610)
Hamburg, 20246
GermanySite Not Available
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 0704)
Szeged, Csongrad 6725
HungarySite Not Available
Pécsi Tudományegyetem Klinikai Központ ( Site 0703)
Pécs, Pecs 7624
HungarySite Not Available
Semmelweis Egyetem ( Site 0701)
Budapest, Pest 1083
HungarySite Not Available
Gottsegen Gyorgy Orszagos Kardiologiai Intezet ( Site 0702)
Budapest, 1096
HungarySite Not Available
Carmel Hospital ( Site 0803)
Haifa, 3436212
IsraelSite Not Available
Rambam Health Care Campus ( Site 0802)
Haifa, 3109601
IsraelSite Not Available
Rabin Medical Center ( Site 0805)
Petah-Tikva, 4941492
IsraelSite Not Available
Sheba Medical Center ( Site 0801)
Ramat Gan, 5265601
IsraelSite Not Available
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905)
Bologna, Emilia-Romagna 40138
ItalySite Not Available
AOU Policlinico Umberto I ( Site 0910)
Roma, Lazio 00161
ItalySite Not Available
Ospedale San Martino ( Site 0901)
Genova, Liguria 16132
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda ( Site 0900)
Milan, Lombardia 20162
ItalySite Not Available
Fondazione IRCCS San Gerardo dei Tintori ( Site 0911)
Monza, Lombardia 20900
ItalySite Not Available
A.O.U. Citta della Salute e della Scienza di Torino ( Site 0904)
Torino, Piemonte 10126
ItalySite Not Available
Azienda Ospedaliera Universitaria Integrata ( Site 0908)
Verona, Veneto 37126
ItalySite Not Available
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0902)
Milano, 20122
ItalySite Not Available
Fondazione IRCCS Policlinico San Matteo ( Site 0909)
Pavia, 27100
ItalySite Not Available
Fondazione G. Monasterio ( Site 0907)
Pisa, 56124
ItalySite Not Available
Ospedale Civile SS Annunziata ( Site 0903)
Sassari, 07100
ItalySite Not Available
Nagoya University Hospital ( Site 2102)
Nagoya, Aichi 466-8560
JapanSite Not Available
National Cerebral and Cardiovascular Center ( Site 2103)
Suita, Osaka 564-8565
JapanSite Not Available
The University of Tokyo Hospital ( Site 2101)
Bunkyo, Tokyo 113-8655
JapanSite Not Available
Kyorin University Hospital ( Site 2100)
Mitaka, Tokyo 181-8611
JapanSite Not Available
Kyushu University Hospital ( Site 2105)
Fukuoka, 812-8582
JapanSite Not Available
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 ofSite Not Available
Pusan National University Hospital ( Site 1305)
Busan, Pusan-Kwangyokshi 49241
Korea, Republic ofSite Not Available
Asan Medical Center ( Site 1303)
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center ( Site 1301)
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital ( Site 1302)
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System ( Site 1300)
Seoul, 03722
Korea, Republic ofSite Not Available
Radboud University Medical Center ( Site 1001)
Nijmegen, Gelderland 6525 GA
NetherlandsSite Not Available
Sint Antonius Ziekenhuis ( Site 1000)
Nieuwegein, Utrecht 3435CM
NetherlandsSite Not Available
Krakowski Szpital Specjalistyczny im. św. Jana Pawła II ( Site 1100)
Krakow, Malopolskie 31-202
PolandSite Not Available
National Heart Centre Singapore ( Site 1201)
Singapore, Central Singapore 169609
SingaporeSite Not Available
National University Heart Centre, Singapore ( Site 1200)
Singapore, Central Singapore 119074
SingaporeSite Not Available
Hospital Universitari Son Espases ( Site 1412)
Palma, Baleares 07120
SpainSite Not Available
Hospital Marques de Valdecilla ( Site 1405)
Santander, Cantabria 39008
SpainSite Not Available
Hospital Clinic de Barcelona ( Site 1406)
Barcelona, Cataluna 08036
SpainSite Not Available
Hospital Vall D Hebron ( Site 1404)
Barcelona, 08035
SpainSite Not Available
Hospital General Universitario 12 de Octubre ( Site 1403)
Madrid, 28041
SpainSite Not Available
Hospital Ramon y Cajal ( Site 1401)
Madrid, 28034
SpainSite Not Available
Hospital Universitario La Paz ( Site 1410)
Madrid, 28046
SpainSite Not Available
Hospital Virgen del Rocio ( Site 1407)
Sevilla, 41013
SpainSite Not Available
Hospital Universitario de Toledo ( Site 1408)
Toledo, 45007
SpainSite Not Available
Kaohsiung Veterans General Hospital ( Site 1503)
Kaohsiung, 813414
TaiwanSite Not Available
National Cheng Kung University Hospital ( Site 1501)
Tainan, 70403
TaiwanSite Not Available
Taipei Veterans General Hospital ( Site 1502)
Taipei, 11217
TaiwanSite Not Available
Faculty of Medicine Siriraj Hospital ( Site 1600)
Bangkok, Krung Thep Maha Nakhon 10700
ThailandSite Not Available
Maharaj Nakorn Chiang Mai Hospital ( Site 1601)
Chiang Mai, 50200
ThailandSite Not Available
Papworth Hospital NHS Foundation Trust ( Site 1802)
Cambridge, Cambridgeshire CB23 3RE
United KingdomActive - Recruiting
Royal Papworth Hospital ( Site 1802)
Cambridge, Cambridgeshire CB2 0AY
United KingdomSite Not Available
Hammersmith Hospital ( Site 1801)
London, London, City Of W12 OHS
United KingdomSite Not Available
Royal Brompton Hospital ( Site 1804)
London, London, City Of SW3 6NP
United KingdomSite Not Available
Royal Free London NHS Foundation Trust ( Site 1803)
London, London, City Of NW3 2QG
United KingdomSite Not Available
Golden Jubilee National Hospital ( Site 1800)
Glasgow, West Dunbartonshire G81 4DY
United KingdomSite Not Available
Pulmonary Associates, PA ( Site 1903)
Phoenix, Arizona 85032
United StatesSite Not Available
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular
Aurora, Colorado 80045
United StatesSite Not Available
Indiana University Health Methodist Hospital ( Site 1905)
Indianapolis, Indiana 46202
United StatesSite Not Available
University of Kansas Medical Center ( Site 1928)
Kansas City, Kansas 66160
United StatesSite Not Available
Norton Pulmonary Specialists ( Site 1935)
Louisville, Kentucky 40202
United StatesSite Not Available
University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)
Albuquerque, New Mexico 87131
United StatesSite Not Available
University of Cincinnati Medical Center ( Site 1927)
Cincinnati, Ohio 45219
United StatesSite Not Available
Ascension Seton Heart Specialty Care and Transplant Center ( Site 1918)
Austin, Texas 78705
United StatesSite Not Available
Froedtert Hospital & the Medical College of Wisconsin ( Site 1934)
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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