- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00377949
Multi-center, Web Based Observational Study of Pulmonary Hypertension in Scleroderma Patients
The Natural History and Outcome of Patients With Scleroderma at High Risk for or With Early Pulmonary Hypertension
Studieoversikt
Status
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
California
-
Los Angeles, California, Forente stater, 90095
- UCLA Medical Center
-
Stanford, California, Forente stater, 94305
- Stanford University
-
-
Colorado
-
Denver, Colorado, Forente stater, 80206
- National Jewish Medical and Research Center
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater, 20007
- Georgetown University Medical Center
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60611
- Northwestern University
-
Chicago, Illinois, Forente stater, 60637
- University of Chicago
-
-
Louisiana
-
New Orleans, Louisiana, Forente stater, 70112
- Louisiana State University Health Science Center
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21224
- John Hopkins University Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02111
- Tufts Medical Center
-
Boston, Massachusetts, Forente stater, 02118
- Boston University Medical School
-
Worcester, Massachusetts, Forente stater, 01605
- University of Massachussetts Memorial Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan-Scleroderma Program
-
-
Minnesota
-
Minneapolis, Minnesota, Forente stater, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Forente stater, 55455
- University of Minnesota
-
-
New Jersey
-
New Brunswick, New Jersey, Forente stater, 08903
- University of Medicine and Dentistry of New Jersey
-
-
New York
-
Albany, New York, Forente stater, 12206
- Center for Rheumatology
-
New Hyde Park, New York, Forente stater, 11040
- North Shore Long Island Jewish Medical Center
-
New York, New York, Forente stater, 10065
- Cornell University
-
New York, New York, Forente stater, 10021
- Hospital for Special Surgery
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania
-
Pittsburgh, Pennsylvania, Forente stater, 15261
- University of Pittsburgh
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- The University of Texas Health Science Center
-
-
Utah
-
Salt Lake City, Utah, Forente stater, 84132
- University of Utah
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forente stater, 53226
- The Medical College of Wisconsin
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Global Inclusion Criteria
- Eligible patients must meet all of the following inclusion criteria:
- Patient ≥ 18 years with a clinical diagnosis of SSc (ACR criteria or the LeRoy criteria for limited or diffuse scleroderma
Specific Inclusion Criteria
- Diagnosis of "pre" pulmonary arterial hypertension defined as:
- Echocardiogram with a resting sPAP of ≥ 40mmHg Or
- Pulmonary function test with FVC >70% and a DLCO <55% of predicted or a FVC/DLco ratio >1.6. or
- Right heart catheterization which shows or a mean PA pressure > 30mmHg with exercise (with a mPAP < 25mmHg at rest)
Patients entered as a 'pre'-pulmonary arterial hypertension who then undergo right heart catheterization and are found to have pulmonary arterial hypertension, pulmonary venous hypertension or diastolic dysfunction or pulmonary hypertension secondary to interstitial lung disease will be followed as a definite PH patient and classified into the appropriate category.
- Diagnosis of definite pulmonary hypertension Patients with pulmonary hypertension with a right heart catheterization showing a mean PA pressure > 25mmHg, diagnosed in the past 6 months.
Classification of PH Group 1 PAH - Patients with mPAP ≥ 25mmHg with a wedge < 15mmHg Group 2 PVH - Patients who have a mean PA pressure ≥ 25mmHg with a wedge pressure which is > 15 mmHg Group 3 PH-ILD Patients who have a mean PA pressure ≥ 25mmHg (on right heart catheterization) who have moderate to severe interstitial fibrosis on HRCT scan with a FVC and TLC < 65% predicted
b. Exclusion Criteria
- Diagnosis and treatment of pulmonary hypertension for > 6 months
- Patients with known severe interstitial fibrosis, pulmonary thrombotic disease, heart failure, cardiomyopathy,history of coronary artery disease or other cardio-pulmonary problems which could cause pulmonary hypertension are not eligible for the 'pre'-pulmonary hypertension but do qualify for the definite pulmonary hypertension group if they have a right heart catheterization showing a mean PAH >25mmHg.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pulmonary Hypertension Progression
Tidsramme: 10 years
|
The primary objective of the study is to determine the timeline of progression from pre-pulmonary hypertension to diagnosable pulmonary hypertension based on right heart catheterization
|
10 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Virginia D. Steen, MD, Georgetown University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Barst RJ, Rubin LJ, Long WA, McGoon MD, Rich S, Badesch DB, Groves BM, Tapson VF, Bourge RC, Brundage BH, Koerner SK, Langleben D, Keller CA, Murali S, Uretsky BF, Clayton LM, Jobsis MM, Blackburn SD, Shortino D, Crow JW; Primary Pulmonary Hypertension Study Group. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. N Engl J Med. 1996 Feb 1;334(5):296-301. doi: 10.1056/NEJM199602013340504.
- Young RH, Mark GJ. Pulmonary vascular changes in scleroderma. Am J Med. 1978 Jun;64(6):998-1004. doi: 10.1016/0002-9343(78)90455-2.
- Salerni R, Rodnan GP, Leon DF, Shaver JA. Pulmonary hypertension in the CREST syndrome variant of progressive systemic sclerosis (scleroderma). Ann Intern Med. 1977 Apr;86(4):394-9. doi: 10.7326/0003-4819-86-4-394.
- Stupi AM, Steen VD, Owens GR, Barnes EL, Rodnan GP, Medsger TA Jr. Pulmonary hypertension in the CREST syndrome variant of systemic sclerosis. Arthritis Rheum. 1986 Apr;29(4):515-24. doi: 10.1002/art.1780290409.
- Steen VD, Ziegler GL, Rodnan GP, Medsger TA Jr. Clinical and laboratory associations of anticentromere antibody in patients with progressive systemic sclerosis. Arthritis Rheum. 1984 Feb;27(2):125-31. doi: 10.1002/art.1780270202.
- Murata I, Takenaka K, Yoshinoya S, Kikuchi K, Kiuchi T, Tanigawa T, Ito K. Clinical evaluation of pulmonary hypertension in systemic sclerosis and related disorders. A Doppler echocardiographic study of 135 Japanese patients. Chest. 1997 Jan;111(1):36-43. doi: 10.1378/chest.111.1.36.
- Denton CP, Cailes JB, Phillips GD, Wells AU, Black CM, Bois RM. Comparison of Doppler echocardiography and right heart catheterization to assess pulmonary hypertension in systemic sclerosis. Br J Rheumatol. 1997 Feb;36(2):239-43. doi: 10.1093/rheumatology/36.2.239.
- MacGregor AJ, Canavan R, Knight C, Denton CP, Davar J, Coghlan J, Black CM. Pulmonary hypertension in systemic sclerosis: risk factors for progression and consequences for survival. Rheumatology (Oxford). 2001 Apr;40(4):453-9. doi: 10.1093/rheumatology/40.4.453.
- Yousem SA. The pulmonary pathologic manifestations of the CREST syndrome. Hum Pathol. 1990 May;21(5):467-74. doi: 10.1016/0046-8177(90)90002-m.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB # 04-227
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
-
Arkansas Children's Hospital Research InstituteEunice Kennedy Shriver National Institute of Child Health and Human Development...AvsluttetSIRS (Systemic Inflammatory Response Syndrome)Forente stater
-
University of ArkansasAvsluttetPediatriske pasienter med SIRS (Systemic Inflammatory Response Syndrome)Forente stater
-
Chinese PLA General HospitalFullførtSepsis | SIRS (Systemic Inflammatory Response Syndrome)Kina
-
Chinese PLA General HospitalUkjentSepsis | SIRS (Systemic Inflammatory Response Syndrome)Kina
-
BiogenGodkjent for markedsføringSuperoxide Dismutase 1-Amyotropic Lateral SclerosisForente stater