Early, Simple and Reliable Detection of Pulmonary Arterial Hypertension (PAH) in Systemic Sclerosis (SSc)
NCT ID: NCT00706082
Last Updated: 2012-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
490 participants
OBSERVATIONAL
2008-10-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Patients with definite diagnosis of SSc by American College of Rheumatology (ACR) criteria (18); including all patients with any other connective tissue diseases (CTD) who, in parallel, meet the ACR criteria for SSc (18)
* SSc disease duration \> 3 years dated from onset of first non-Raynaud feature
* Diffusing capacity of the lung for carbon monoxide (DLCO) \< 60% of predicted
Exclusion Criteria
* RHC within the 12 months before enrolment
* Use of therapy that is considered definite PAH/PH treatment (19) for any indication, within the 6 weeks before enrolment and/or for a total of more than 6 weeks during the 12 months before enrolment: i.e. endothelin receptor antagonists (ERA; e.g. bosentan, sitaxsentan, ambrisentan), phosphodiesterase type 5 inhibitors (PDE5; e.g. sildenafil, tadalafil, vardenafil), prostanoids (e.g. epoprostenol, treprostinil, iloprost, beraprost), and any experimental PAH/PH drugs. Intermittent use of PDE5 inhibitors for male erectile dysfunction is permitted
* Forced vital capacity (FVC) \< 40%
* Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \< 40 ml/min/1.73 m2 (20), assessed according to local practice
* Previous evidence or previous diagnosis of clinically relevant left heart disease and other relevant conditions, i.e. at least one of the following:
* Previous ECHO with estimated left ventricular (LV) ejection fraction \< 50%, previous history of cardiogenic pulmonary edema, increased size of left atrium (\> 50 mm)
* Known significant diastolic dysfunction associated with clinical heart failure or PCWP \> 15mmHg
* Known significant coronary disease or significant valvular heart disease
* Evidence of inadequately treated blood pressure, defined as \> 160/90 mmHg and/or blood pressure during exercise \> 220/120 mmHg (if evaluated)
* Known hypertrophic cardiomyopathy or left ventricular hypertrophy (interventricular septum thickness (IVS) or posterior wall thickness (PWD) \> 1.2 cm)
* Patients referred with overt heart failure
* Known congenital heart defects such as single ventricle, transposition, or Eisenmenger physiology
* Previous closure of systemic pulmonary shunt, heart valve replacement, or cardiac transplantation
* Pregnancy: pregnancy testing in females with child-bearing potential is mandatory and must be done before enrolment
* Patients unlikely to be available for annual follow up over an anticipated 3 years of study (e.g. survival estimate, psychological, logistics; based on investigator discretion)
Patients with clinically relevant left heart disease as defined above, diagnosed by ECHO at baseline (i.e. after enrolment), will be included in the study.
* During the study, use of therapy that is considered definite PAH/PH treatment (19) is prohibited and will result in discontinuation of the patient from the study, unless the total treatment duration per year is less than 6 weeks. Intermittent use of PDE5 inhibitors for male erectile dysfunction is permitted.
* During the study, use of therapy that is considered definite PAH/PH treatment (19) is prohibited within the 6 weeks preceding the follow-up visits. Violation of this rule will result in discontinuation of the patient from the study.
18 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham, 311 THT
Birmingham, Alabama, United States
UCLA Division of Rheumatology
Los Angeles, California, United States
Harbor UCLA Medical Center
Torrance, California, United States
University of CT
Farmington, Connecticut, United States
Department of Rheumatology
Washington D.C., District of Columbia, United States
University of Florida
Jacksonville, Florida, United States
Rheumatology, MC 733, The University of Illinois-Chicago
Chicago, Illinois, United States
John Hopkins, Division of Rheumatology
Baltimore, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
University of Michigan Scleroderma Program
Ann Arbor, Michigan, United States
Michigan State University
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic - Division of Rheumatology
Rochester, Minnesota, United States
The Center for Rheumatology
Albany, New York, United States
Division of Rheumatology and Allergy - Clinical Immunology
Lake Success, New York, United States
AAIR Research Center
Rochester, New York, United States
Carolina Arthritis
Wilmington, North Carolina, United States
Chief of Rheumatology
Toledo, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Division of Rheumatolgoy and Immunology
Charleston, South Carolina, United States
Department of Critical Care - Virginia Mason Medical Center
Seattle, Washington, United States
Arthritis Northwest
Spokane, Washington, United States
Medical College of Wisconsin and Froedtert Hospital
Milwaukee, Wisconsin, United States
Division of Pulmonology, MEDUK
Graz, , Austria
Universitaetsklinik fuer Dermatologie und Venerologie
Innsbruck, , Austria
Abteilung für Dermatologie
Linz, , Austria
Univ - Klinik fuer Innere Medizin II, Abt. fuer Kardiologie - Medizinische Universitaetsklinik Wien
Vienna, , Austria
Clinic for Heart and Rheumatic Diseases
Sarajevo, , Bosnia and Herzegovina
Santa Casa de BH - Departamento de Reumatologia
Belo Horizonte, , Brazil
Clinical Hospital - UNICAMP University of Campinas
Campinas, , Brazil
Clinical Hospital - Federal University of Parana State - Rheumatology and Systemic Sclerosis Department
Curitiba, , Brazil
UFRJ - Serviço de Reumatologia
Ilha Do Fundão, , Brazil
Complexo Santa Casa de POA - Hospital Santa Clara
Porto Alegre, , Brazil
Hospital São Lucas da PUCRS - Pontifícia Universidade Católica de Porto Alegre (PUCRS)
Porto Alegre, , Brazil
Clinical Hospital - Medicine School of the University of Sao Paulo
São Paulo, , Brazil
Clinical Hospital - Federal University of Medicine of Sao Paulo
São Paulo, , Brazil
Faculty of Medicine
Calgary, Alberta, Canada
2E4.31 Walter Mackenzie Health Sciences Center
Edmonton, Alberta, Canada
Regent Medical Building
Vancouver, British Columbia, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre-VG Site
Halifax, Nova Scotia, Canada
St. Joseph Health Care
London, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Hospital Notre-Dame
Montreal, Quebec, Canada
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, Canada
St. Paul's (Grey Nuns) Hospital
Saskatoon, Saskatchewan, Canada
Peking Union Medical College Hospital (West Campus) Chinese Academy of Medical Sciences
Beijing, , China
Revmatologicky ustav
Prague, , Czechia
Kerckhoff-Klinik GmbH - Abteilung Rheumatologie und Kliniscihe Immunologie
Bad Nauheim, , Germany
Universitaetsmedizine Charite
Berlin, , Germany
Universitaetsklinikum Bonnn
Bonn, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, , Germany
Medizinische Klinik 3, Rheumatologie, Immunologie und Onkologie
Erlangen, , Germany
Goethe-Universitaet Frankfurt
Frankfurt, , Germany
Medizinische Klinik der Albert-Ludwigs Universitaet Freiburg
Freiburg im Breisgau, , Germany
Universitatsklinik Greifswald - Klinik fur Innere Medizin B
Greifswald, , Germany
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Medizinische Klinik und Poliklinik B, Rheumatologisch Immunologische Ambulanz
Münster, , Germany
Brüder Krankenhaus
Trier, , Germany
University Hospital Zurich
Zurich, , Germany
Kardiovaszkuláris Ambulancia Kft.
Debrecen, , Hungary
Pécs, , Hungary
UMC St Radboud
Nijmegen, , Netherlands
Helse Bergen HF Haukeland Universitetssykehus
Bergen, , Norway
Rikshospitalet, University hospital of Oslo - Rheumatology department
Oslo, , Norway
St. Olav University Hospital - Rheumatologisk avdeling
Trondheim, , Norway
Prywatny Specjalistyczny Gabinet Profesora Stanislawa
Bialystok, , Poland
UPR - Medical Sciences Campus
San Juan, , Puerto Rico
Clinica de Reumatologie
Cluj-Napoca, , Romania
State Institution "Institute of the Rheumatology of the Russian Academy of Medical Sciences"
Moscow, , Russia
The National Institute of Rheumatic Diseases
Piešťany, , Slovakia
HOSPITAL SANTA CREU i SANT PAU
Barcelona, , Spain
Servicio de Medicina Interna Planta 2ºB
Bizkaia, , Spain
Jefe de Servicio - Servicio de Rheumatología
Valencia, , Spain
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
Adana, , Turkey (Türkiye)
Ankara Numune Egitim ve Arastirma hastanesi
Ankara, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Ege Universitesi
Izmir, , Turkey (Türkiye)
Royal Free Hospital NHS Trust
London, , United Kingdom
Countries
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References
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Gopal DM, Doldt B, Finch K, Simms RW, Farber HW, Gokce N. Relation of novel echocardiographic measures to invasive hemodynamic assessment in scleroderma-associated pulmonary arterial hypertension. Arthritis Care Res (Hoboken). 2014 Sep;66(9):1386-94. doi: 10.1002/acr.22307.
Other Identifiers
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AC-052-510
Identifier Type: -
Identifier Source: org_study_id
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