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

21. juni 2012 oppdatert av: Actelion

A Two-stage Prospective Observational Cohort Study in Scleroderma Patients to Evaluate Screening Tests and the Incidence of Pulmonary Arterial Hypertension and Pulmonary Hypertension

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

Studieoversikt

Status

Avsluttet

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

490

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Pulmonary arterial hypertension (PAH) confirmed by right heart catheterization (RHC)
Tidsramme: Baseline and 3-year follow-up
Baseline and 3-year follow-up

Sekundære resultatmål

Resultatmål
Tidsramme
Pulmonary hypertension (PH) confirmed by right heart catheterization (RHC)
Tidsramme: Baseline and 3-year follow-up
Baseline and 3-year follow-up

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Actelion

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2008

Primær fullføring (Faktiske)

1. november 2011

Studiet fullført (Faktiske)

1. mars 2012

Datoer for studieregistrering

Først innsendt

25. juni 2008

Først innsendt som oppfylte QC-kriteriene

26. juni 2008

Først lagt ut (Anslag)

27. juni 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

25. juni 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juni 2012

Sist bekreftet

1. juni 2012

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AC-052-510

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Systemisk sklerose

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Serbia

Forhold

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Legemiddelintervensjoner

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