- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00706082
Early, Simple and Reliable Detection of Pulmonary Arterial Hypertension (PAH) in Systemic Sclerosis (SSc) (DETECT)
A Two-stage Prospective Observational Cohort Study in Scleroderma Patients to Evaluate Screening Tests and the Incidence of Pulmonary Arterial Hypertension and Pulmonary Hypertension
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Bad Nauheim, Alemanha, 61231
- Kerckhoff-Klinik GmbH - Abteilung Rheumatologie und Kliniscihe Immunologie
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Berlin, Alemanha, 10117
- Universitaetsmedizine Charite
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Bonn, Alemanha, 53105
- Universitaetsklinikum Bonnn
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Dresden, Alemanha, 01307
- Universitaetsklinikum Carl Gustav Carus
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Erlangen, Alemanha, 91054
- Medizinische Klinik 3, Rheumatologie, Immunologie und Onkologie
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Frankfurt, Alemanha, 60590
- Goethe-Universitaet Frankfurt
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Freiburg, Alemanha, 79106
- Medizinische Klinik der Albert-Ludwigs Universitaet Freiburg
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Greifswald, Alemanha, D-17487
- Universitatsklinik Greifswald - Klinik fur Innere Medizin B
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Heidelberg, Alemanha
- Thoraxklinik am Universitatsklinikum Heidelberg
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Koeln, Alemanha, 50924
- Universitaetsklinikum Koeln
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Leipzig, Alemanha, 04103
- Universitaetsklinikum Leipzig
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Muenster, Alemanha, 48149
- Medizinische Klinik und Poliklinik B, Rheumatologisch Immunologische Ambulanz
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Trier, Alemanha
- Brüder Krankenhaus
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Zurich, Alemanha
- University Hospital Zurich
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Belo Horizonte, Brasil, CEP: 30150-221 - BH
- Santa Casa de BH - Departamento de Reumatologia
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Campinas, Brasil, CEP 13083-970
- Clinical Hospital - UNICAMP University of Campinas
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Curitiba, Brasil, CEP 80060-240
- Clinical Hospital - Federal University of Parana State - Rheumatology and Systemic Sclerosis Department
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Ilha do Fundão, Brasil, CEP: 21941-590
- UFRJ - Serviço de Reumatologia
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Porto Alegre, Brasil, CEP 90020-160
- Complexo Santa Casa de POA - Hospital Santa Clara
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Porto Alegre, Brasil, CEP 90610-000
- Hospital São Lucas da PUCRS - Pontifícia Universidade Católica de Porto Alegre (PUCRS)
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São Paulo, Brasil, CEP 01246 - 000
- Clinical Hospital - Medicine School of the University of Sao Paulo
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São Paulo, Brasil, CEP 04023 - 062
- Clinical Hospital - Federal University of Medicine of Sao Paulo
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Sarajevo, Bósnia e Herzegovina, 71 000
- Clinic for Heart and Rheumatic Diseases
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Alberta
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Calgary, Alberta, Canadá, T1Y 6J4
- Faculty of Medicine
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Edmonton, Alberta, Canadá, T6G 2B7
- 2E4.31 Walter Mackenzie Health Sciences Center
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British Columbia
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Vancouver, British Columbia, Canadá, V6K 2E1
- Regent Medical Building
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Manitoba
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Winnipeg, Manitoba, Canadá, R3A 1M4
- University of Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 2Y9
- Queen Elizabeth II Health Sciences Centre-VG Site
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Ontario
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London, Ontario, Canadá, N6A 4V2
- St. Joseph Health Care
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Toronto, Ontario, Canadá, M5G 1X5
- Mount Sinai Hospital
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Quebec
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Montreal, Quebec, Canadá, H2L 4M1
- Hospital Notre-Dame
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Montreal, Quebec, Canadá, H3T 1E2
- Sir Mortimer B Davis Jewish General Hospital
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7K 0H6
- St. Paul's (Grey Nuns) Hospital
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Beijing, China, 100032
- Peking Union Medical College Hospital (West Campus) Chinese Academy of Medical Sciences
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Piestany, Eslováquia, 921 12
- The National Institute of Rheumatic Diseases
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Barcelona, Espanha, 08025
- Hospital Santa Creu i Sant Pau
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Bizkaia, Espanha, 48903
- Servicio de Medicina Interna Planta 2ºB
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Valencia, Espanha, 46017
- Jefe de Servicio - Servicio de Rheumatología
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham, 311 THT
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California
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Los Angeles, California, Estados Unidos, 90095
- UCLA Division of Rheumatology
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Torrance, California, Estados Unidos, 90509
- Harbor Ucla Medical Center
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06030
- University of CT
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20007
- Department of rheumatology
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Florida
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Jacksonville, Florida, Estados Unidos, 32209
- University of Florida
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rheumatology, MC 733, The University of Illinois-Chicago
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- John Hopkins, Division of Rheumatology
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston University School of Medicine
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- University of Michigan Scleroderma Program
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Grand Rapids, Michigan, Estados Unidos, 49546
- Michigan State University
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic - Division of Rheumatology
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New York
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Albany, New York, Estados Unidos, 12206
- The Center for Rheumatology
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Lake Success, New York, Estados Unidos, 11042
- Division of Rheumatology and Allergy - Clinical Immunology
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Rochester, New York, Estados Unidos, 14618
- AAIR Research Center
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North Carolina
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Wilmington, North Carolina, Estados Unidos, 28401
- Carolina Arthritis
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Ohio
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Toledo, Ohio, Estados Unidos, 43614
- Chief of Rheumatology
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University Hospital
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Medical University of South Carolina, Division of Rheumatolgoy and Immunology
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Washington
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Seattle, Washington, Estados Unidos, 98101
- Department of Critical Care - Virginia Mason Medical Center
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Spokane, Washington, Estados Unidos, 99204
- Arthritis Northwest
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin and Froedtert Hospital
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Moscow, Federação Russa, 115522
- State Institution "Institute of the Rheumatology of the Russian Academy of Medical Sciences"
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Nijmegen, Holanda, 6500
- UMC St Radboud
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Debrecen, Hungria, 4032
- Kardiovaszkuláris Ambulancia Kft.
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Pecs, Hungria, 7624
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Bergen, Noruega, 5053
- Helse Bergen HF Haukeland universitetssykehus
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Oslo, Noruega, 0027
- Rikshospitalet, University hospital of Oslo - Rheumatology department
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Trondheim, Noruega, 7030
- St. Olav University Hospital - Rheumatologisk avdeling
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Adana, Peru
- Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
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Ankara, Peru, 06100
- Hacettepe Universitesi Tip Fakultesi
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Ankara, Peru, 06100
- Ankara Numune Egitim ve Arastirma Hastanesi
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Istanbul, Peru, 34390
- Istanbul Universitesi Istanbul Tip Fakultesi
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Izmir, Peru, 35100
- Ege Üniversitesi
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Bialystok, Polônia, PL-15-297
- Prywatny Specjalistyczny Gabinet Profesora Stanislawa
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San Juan, Porto Rico, 00936
- UPR - Medical Sciences Campus
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London, Reino Unido
- Royal Free Hospital NHS Trust
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Praha, República Checa, 128 50
- Revmatologicky Ustav
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Cluj Napoca, Romênia, 400006
- Clinica de Reumatologie
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Geneve, Suíça, 1211
- Hôpitaux Universitaires de Genève
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Graz, Áustria
- Division of Pulmonology, MEDUK
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Innsbruck, Áustria, A-6020
- Universitaetsklinik fuer Dermatologie und Venerologie
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Linz, Áustria, A-4010
- Abteilung für Dermatologie
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Wien, Áustria, A1090
- Univ - Klinik fuer Innere Medizin II, Abt. fuer Kardiologie - Medizinische Universitaetsklinik Wien
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Pulmonary arterial hypertension (PAH) confirmed by right heart catheterization (RHC)
Prazo: Baseline and 3-year follow-up
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Baseline and 3-year follow-up
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Pulmonary hypertension (PH) confirmed by right heart catheterization (RHC)
Prazo: Baseline and 3-year follow-up
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Baseline and 3-year follow-up
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doenças cardiovasculares
- Doenças Vasculares
- Doenças de pele
- Doenças Respiratórias
- Doenças pulmonares
- Doenças do Tecido Conjuntivo
- Esclerose
- Hipertensão
- Esclerodermia Sistêmica
- Esclerodermia Difusa
- Hipertensão arterial pulmonar
- Hipertensão Pulmonar Primária Familiar
- Hipertensão Pulmonar
Outros números de identificação do estudo
- AC-052-510
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