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Trial record 3 of 4 for:    8532025 [PUBMED-IDS]

Multi-center, Web Based Observational Study of Pulmonary Hypertension in Scleroderma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00377949
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : May 3, 2016
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Virginia Steen, MD, Georgetown University

Tracking Information
First Submitted Date September 18, 2006
First Posted Date September 19, 2006
Last Update Posted Date May 3, 2016
Study Start Date February 2005
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 9, 2015)
Pulmonary Hypertension Progression [ Time Frame: 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
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00377949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multi-center, Web Based Observational Study of Pulmonary Hypertension in Scleroderma Patients
Official Title The Natural History and Outcome of Patients With Scleroderma at High Risk for or With Early Pulmonary Hypertension
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 the timeline for progression from diagnosable pulmonary hypertension to clinical worsening of disease as defined as death, hospitalization, or worsening of PHT symptoms.
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 is now the cause of all scleroderma related deaths. New therapeutic advances have improved short-term management of pulmonary hypertension in scleroderma, but long-term outcomes are unknown. With this in mind, Dr. Steen has developed Pulmonary Hypertension Assessment Registry of Scleroderma (PHAROS), a preventive, multi-center, web based observational study that looks at the natural history and outcome of scleroderma patients who are at high risk or have early pulmonary hypertension. Patients entered into the registry will be followed in prospective fashion noting the clinical course of disease by both scheduled and event driven follow up. A thorough baseline history will be collected to determine key prognostic and correlative factors for both disease prevalence and progression. Yearly follow up consisting of questionnaires, pulmonary function tests, echocardiogram, 6 minute walk tests and predefined patient characteristics will also be conducted to further understand and note the progression of scleroderma related PAH. Event driven follow up will occur to record findings and record specific predetermined events in the clinical course of disease.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum stored for future analysis
Sampling Method Non-Probability Sample
Study Population Primary care, rheumatology and pulmonary hypertension clinics.
Condition
  • Systemic Sclerosis
  • Scleroderma
  • Pulmonary Hypertension
  • Pulmonary Arterial Hypertension
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 2, 2016)
602
Original Enrollment
 (submitted: September 18, 2006)
400
Study Completion Date Not Provided
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria
  1. 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
  2. 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00377949
Other Study ID Numbers IRB # 04-227
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Virginia Steen, MD, Georgetown University
Study Sponsor Georgetown University
Collaborators Gilead Sciences
Investigators
Principal Investigator: Virginia D. Steen, MD Georgetown University
PRS Account Georgetown University
Verification Date May 2016