Early, Simple and Reliable Detection of Pulmonary Arterial Hypertension (PAH) in Systemic Sclerosis (SSc) (DETECT)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00706082
First received: June 25, 2008
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

A two-stage prospective observational cohort study in scleroderma patients to evaluate screening tests and the incidence of pulmonary arterial hypertension and pulmonary hypertension


Condition
Systemic Sclerosis
Pulmonary Arterial Hypertension
Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Two-stage Prospective Observational Cohort Study in Scleroderma Patients to Evaluate Screening Tests and the Incidence of Pulmonary Arterial Hypertension and Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Pulmonary arterial hypertension (PAH) confirmed by right heart catheterization (RHC) [ Time Frame: Baseline and 3-year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary hypertension (PH) confirmed by right heart catheterization (RHC) [ Time Frame: Baseline and 3-year follow-up ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum and plasma samples will be stored at a central laboratory for at least two additional years after official study termination.


Enrollment: 490
Study Start Date: October 2008
Study Completion Date: March 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with scleroderma in USA, Canada, UK, Germany, Switzerland, Austria, The Netherlands, Belgium, Sweden, Slovakia, and Turkey.

Criteria

Inclusion criteria

  • Male or female
  • 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

  • PH confirmed by RHC before enrolment, i.e. mean pulmonary arterial pressure (mPAP) > or = 25 mmHg at rest or > or = 30 mmHg at exercise, independent of PCWP (11)
  • 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.

Additional exclusion criteria after patient enrolment

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706082

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham, 311 THT
Birmingham, Alabama, United States, 35294
United States, California
UCLA Division of Rheumatology
Los Angeles, California, United States, 90095
Harbor UCLA Medical Center
Torrance, California, United States, 90509
United States, Connecticut
University of CT
Farmington, Connecticut, United States, 06030
United States, District of Columbia
Department of Rheumatology
Washington, District of Columbia, United States, 20007
United States, Florida
University of Florida
Jacksonville, Florida, United States, 32209
United States, Illinois
Rheumatology, MC 733, The University of Illinois-Chicago
Chicago, Illinois, United States, 60612
United States, Maryland
John Hopkins, Division of Rheumatology
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan Scleroderma Program
Ann Arbor, Michigan, United States, 48106
Michigan State University
Grand Rapids, Michigan, United States, 49546
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic - Division of Rheumatology
Rochester, Minnesota, United States, 55905
United States, New York
The Center for Rheumatology
Albany, New York, United States, 12206
Division of Rheumatology and Allergy - Clinical Immunology
Lake Success, New York, United States, 11042
AAIR Research Center
Rochester, New York, United States, 14618
United States, North Carolina
Carolina Arthritis
Wilmington, North Carolina, United States, 28401
United States, Ohio
Chief of Rheumatology
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina, Division of Rheumatolgoy and Immunology
Charleston, South Carolina, United States, 29425
United States, Washington
Department of Critical Care - Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Arthritis Northwest
Spokane, Washington, United States, 99204
United States, Wisconsin
Medical College of Wisconsin and Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Austria
Division of Pulmonology, MEDUK
Graz, Austria
Universitaetsklinik fuer Dermatologie und Venerologie
Innsbruck, Austria, A-6020
Abteilung für Dermatologie
Linz, Austria, A-4010
Univ - Klinik fuer Innere Medizin II, Abt. fuer Kardiologie - Medizinische Universitaetsklinik Wien
Wien, Austria, A1090
Bosnia and Herzegovina
Clinic for Heart and Rheumatic Diseases
Sarajevo, Bosnia and Herzegovina, 71 000
Brazil
Santa Casa de BH - Departamento de Reumatologia
Belo Horizonte, Brazil, CEP: 30150-221 - BH
Clinical Hospital - UNICAMP University of Campinas
Campinas, Brazil, CEP 13083-970
Clinical Hospital - Federal University of Parana State - Rheumatology and Systemic Sclerosis Department
Curitiba, Brazil, CEP 80060-240
UFRJ - Serviço de Reumatologia
Ilha do Fundão, Brazil, CEP: 21941-590
Hospital São Lucas da PUCRS - Pontifícia Universidade Católica de Porto Alegre (PUCRS)
Porto Alegre, Brazil, CEP 90610-000
Complexo Santa Casa de POA - Hospital Santa Clara
Porto Alegre, Brazil, CEP 90020-160
Clinical Hospital - Medicine School of the University of Sao Paulo
São Paulo, Brazil, CEP 01246 - 000
Clinical Hospital - Federal University of Medicine of Sao Paulo
São Paulo, Brazil, CEP 04023 - 062
Canada, Alberta
Faculty of Medicine
Calgary, Alberta, Canada, T1Y 6J4
2E4.31 Walter Mackenzie Health Sciences Center
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Regent Medical Building
Vancouver, British Columbia, Canada, V6K 2E1
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3A 1M4
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre-VG Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
St. Joseph Health Care
London, Ontario, Canada, N6A 4V2
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Hospital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Canada, Saskatchewan
St. Paul's (Grey Nuns) Hospital
Saskatoon, Saskatchewan, Canada, S7K 0H6
China
Peking Union Medical College Hospital (West Campus) Chinese Academy of Medical Sciences
Beijing, China, 100032
Czech Republic
Revmatologicky ustav
Praha, Czech Republic, 128 50
Germany
Kerckhoff-Klinik GmbH - Abteilung Rheumatologie und Kliniscihe Immunologie
Bad Nauheim, Germany, 61231
Universitaetsmedizine Charite
Berlin, Germany, 10117
Universitaetsklinikum Bonnn
Bonn, Germany, 53105
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Medizinische Klinik 3, Rheumatologie, Immunologie und Onkologie
Erlangen, Germany, 91054
Goethe-Universitaet Frankfurt
Frankfurt, Germany, 60590
Medizinische Klinik der Albert-Ludwigs Universitaet Freiburg
Freiburg, Germany, 79106
Universitatsklinik Greifswald - Klinik fur Innere Medizin B
Greifswald, Germany, D-17487
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitaetsklinikum Koeln
Koeln, Germany, 50924
Universitaetsklinikum Leipzig
Leipzig, Germany, 04103
Medizinische Klinik und Poliklinik B, Rheumatologisch Immunologische Ambulanz
Muenster, Germany, 48149
Brüder Krankenhaus
Trier, Germany
University Hospital Zurich
Zurich, Germany
Hungary
Kardiovaszkuláris Ambulancia Kft.
Debrecen, Hungary, 4032
Pecs, Hungary, 7624
Netherlands
UMC St Radboud
Nijmegen, Netherlands, 6500
Norway
Helse Bergen HF Haukeland Universitetssykehus
Bergen, Norway, 5053
Rikshospitalet, University hospital of Oslo - Rheumatology department
Oslo, Norway, 0027
St. Olav University Hospital - Rheumatologisk avdeling
Trondheim, Norway, 7030
Poland
Prywatny Specjalistyczny Gabinet Profesora Stanislawa
Bialystok, Poland, PL-15-297
Puerto Rico
UPR - Medical Sciences Campus
San Juan, Puerto Rico, 00936
Romania
Clinica de Reumatologie
Cluj Napoca, Romania, 400006
Russian Federation
State Institution "Institute of the Rheumatology of the Russian Academy of Medical Sciences"
Moscow, Russian Federation, 115522
Slovakia
The National Institute of Rheumatic Diseases
Piestany, Slovakia, 921 12
Spain
HOSPITAL SANTA CREU i SANT PAU
Barcelona, Spain, 08025
Servicio de Medicina Interna Planta 2ºB
Bizkaia, Spain, 48903
Jefe de Servicio - Servicio de Rheumatología
Valencia, Spain, 46017
Switzerland
Hopitaux Universitaires de Geneve
Geneve, Switzerland, 1211
Turkey
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
Adana, Turkey
Hacettepe Universitesi Tip Fakultesi
Ankara, Turkey, 06100
Ankara Numune Egitim ve Arastirma hastanesi
Ankara, Turkey, 06100
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, Turkey, 34390
Ege Universitesi
Izmir, Turkey, 35100
United Kingdom
Royal Free Hospital NHS Trust
London, United Kingdom
Sponsors and Collaborators
Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00706082     History of Changes
Other Study ID Numbers: AC-052-510
Study First Received: June 25, 2008
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
United Kingdom: Research Ethics Committee
Germany: Ethics Commission
Switzerland: Ethikkommission
Austria: Ethikkommission
Netherlands: Independent Ethics Committee
Belgium: Institutional Review Board
Sweden: Institutional Review Board
Turkey: Ethics Committee

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014