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

NCT00706082 | Terminated

• 1 other identifier: AC-052-510
• Study Type: observational
• Target: 490
• Locations: 20 countries
• Sites: 83

Brief Summary

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

Conditions

Systemic Sclerosis; Pulmonary Arterial Hypertension; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Pulmonary arterial hypertension (PAH) confirmed by right heart catheterization (RHC)

  Baseline and 3-year follow-up

Secondary Outcomes (1)

• Pulmonary hypertension (PH) confirmed by right heart catheterization (RHC)

  Baseline and 3-year follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Actelion: lead

Study Sites (83)

University of Alabama at Birmingham, 311 THT

Birmingham, Alabama, 35294, United States

Location

UCLA Division of Rheumatology

Los Angeles, California, 90095, United States

Location

Harbor UCLA Medical Center

Torrance, California, 90509, United States

Location

University of CT

Farmington, Connecticut, 06030, United States

Location

Department of Rheumatology

Washington D.C., District of Columbia, 20007, United States

Location

University of Florida

Jacksonville, Florida, 32209, United States

Location

Rheumatology, MC 733, The University of Illinois-Chicago

Chicago, Illinois, 60612, United States

Location

John Hopkins, Division of Rheumatology

Baltimore, Maryland, 21224, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

University of Michigan Scleroderma Program

Ann Arbor, Michigan, 48106, United States

Location

Michigan State University

Grand Rapids, Michigan, 49546, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic - Division of Rheumatology

Rochester, Minnesota, 55905, United States

Location

The Center for Rheumatology

Albany, New York, 12206, United States

Location

Division of Rheumatology and Allergy - Clinical Immunology

Lake Success, New York, 11042, United States

Location

AAIR Research Center

Rochester, New York, 14618, United States

Location

Carolina Arthritis

Wilmington, North Carolina, 28401, United States

Location

Chief of Rheumatology

Toledo, Ohio, 43614, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina, Division of Rheumatolgoy and Immunology

Charleston, South Carolina, 29425, United States

Location

Department of Critical Care - Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Arthritis Northwest

Spokane, Washington, 99204, United States

Location

Medical College of Wisconsin and Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Division of Pulmonology, MEDUK

Graz, Austria

Location

Universitaetsklinik fuer Dermatologie und Venerologie

Innsbruck, A-6020, Austria

Location

Abteilung für Dermatologie

Linz, A-4010, Austria

Location

Univ - Klinik fuer Innere Medizin II, Abt. fuer Kardiologie - Medizinische Universitaetsklinik Wien

Vienna, A1090, Austria

Location

Clinic for Heart and Rheumatic Diseases

Sarajevo, 71 000, Bosnia and Herzegovina

Location

Santa Casa de BH - Departamento de Reumatologia

Belo Horizonte, CEP: 30150-221 - BH, Brazil

Location

Clinical Hospital - UNICAMP University of Campinas

Campinas, CEP 13083-970, Brazil

Location

Clinical Hospital - Federal University of Parana State - Rheumatology and Systemic Sclerosis Department

Curitiba, CEP 80060-240, Brazil

Location

UFRJ - Serviço de Reumatologia

Ilha Do Fundão, CEP: 21941-590, Brazil

Location

Complexo Santa Casa de POA - Hospital Santa Clara

Porto Alegre, CEP 90020-160, Brazil

Location

Hospital São Lucas da PUCRS - Pontifícia Universidade Católica de Porto Alegre (PUCRS)

Porto Alegre, CEP 90610-000, Brazil

Location

Clinical Hospital - Medicine School of the University of Sao Paulo

São Paulo, CEP 01246 - 000, Brazil

Location

Clinical Hospital - Federal University of Medicine of Sao Paulo

São Paulo, CEP 04023 - 062, Brazil

Location

Faculty of Medicine

Calgary, Alberta, T1Y 6J4, Canada

Location

2E4.31 Walter Mackenzie Health Sciences Center

Edmonton, Alberta, T6G 2B7, Canada

Location

Regent Medical Building

Vancouver, British Columbia, V6K 2E1, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3A 1M4, Canada

Location

Queen Elizabeth II Health Sciences Centre-VG Site

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

St. Joseph Health Care

London, Ontario, N6A 4V2, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Hospital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

St. Paul's (Grey Nuns) Hospital

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Peking Union Medical College Hospital (West Campus) Chinese Academy of Medical Sciences

Beijing, 100032, China

Location

Revmatologicky ustav

Prague, 128 50, Czechia

Location

Kerckhoff-Klinik GmbH - Abteilung Rheumatologie und Kliniscihe Immunologie

Bad Nauheim, 61231, Germany

Location

Universitaetsmedizine Charite

Berlin, 10117, Germany

Location

Universitaetsklinikum Bonnn

Bonn, 53105, Germany

Location

Universitaetsklinikum Koeln

Cologne, 50924, Germany

Location

Universitaetsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Medizinische Klinik 3, Rheumatologie, Immunologie und Onkologie

Erlangen, 91054, Germany

Location

Goethe-Universitaet Frankfurt

Frankfurt, 60590, Germany

Location

Medizinische Klinik der Albert-Ludwigs Universitaet Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitatsklinik Greifswald - Klinik fur Innere Medizin B

Greifswald, D-17487, Germany

Location

Thoraxklinik am Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

Medizinische Klinik und Poliklinik B, Rheumatologisch Immunologische Ambulanz

Münster, 48149, Germany

Location

Brüder Krankenhaus

Trier, Germany

Location

University Hospital Zurich

Zurich, Germany

Location

Kardiovaszkuláris Ambulancia Kft.

Debrecen, 4032, Hungary

Location

Unknown Facility

Pécs, 7624, Hungary

Location

UMC St Radboud

Nijmegen, 6500, Netherlands

Location

Helse Bergen HF Haukeland Universitetssykehus

Bergen, 5053, Norway

Location

Rikshospitalet, University hospital of Oslo - Rheumatology department

Oslo, 0027, Norway

Location

St. Olav University Hospital - Rheumatologisk avdeling

Trondheim, 7030, Norway

Location

Prywatny Specjalistyczny Gabinet Profesora Stanislawa

Bialystok, PL-15-297, Poland

Location

UPR - Medical Sciences Campus

San Juan, 00936, Puerto Rico

Location

Clinica de Reumatologie

Cluj-Napoca, 400006, Romania

Location

State Institution "Institute of the Rheumatology of the Russian Academy of Medical Sciences"

Moscow, 115522, Russia

Location

The National Institute of Rheumatic Diseases

Piešťany, 921 12, Slovakia

Location

HOSPITAL SANTA CREU i SANT PAU

Barcelona, 08025, Spain

Location

Servicio de Medicina Interna Planta 2ºB

Bizkaia, 48903, Spain

Location

Jefe de Servicio - Servicio de Rheumatología

Valencia, 46017, Spain

Location

Hopitaux Universitaires de Geneve

Geneva, 1211, Switzerland

Location

Cukurova Universitesi Tip Fakultesi Balcali Hastanesi

Adana, Turkey (Türkiye)

Location

Ankara Numune Egitim ve Arastirma hastanesi

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi

Ankara, 06100, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi

Istanbul, 34390, Turkey (Türkiye)

Location

Ege Universitesi

Izmir, 35100, Turkey (Türkiye)

Location

Royal Free Hospital NHS Trust

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24515598 DERIVED

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.

MeSH Terms

Conditions

Scleroderma, Systemic; Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 27, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2012
• Last Updated: June 25, 2012

Record last verified: 2012-06

Locations

BO (1); HU (2); CN (1); BR (8); DE (14); SL (1); AU (4); RO (1); PR (1); NL (1); NO (3); PL (1); CA (10); CH (1); TU (5); CZ (1); ES (3); RU (1); GB (1); US (23)