Status:
COMPLETED
Multi-center, Web Based Observational Study of Pulmonary Hypertension in Scleroderma Patients
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Gilead Sciences
Conditions:
Systemic Sclerosis
Scleroderma
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is to determine the timeline of progression from pre-pulmonary hypertension to diagnosable pulmonary hypertension based on right heart catheterization. Moreover, to determine...
Detailed Description
Systemic sclerosis (SSc) is a rare, often fatal idiopathic disease, which has no effective therapy. One of the most major complications of systematic sclerosis is pulmonary hypertension (PHT), which i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT00377949
Start Date
February 1 2005
Last Update
May 3 2016
Active Locations (25)
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1
UCLA Medical Center
Los Angeles, California, United States, 90095
2
Stanford University
Stanford, California, United States, 94305
3
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
4
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007