Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2005-07-31
2012-07-31
Brief Summary
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Hypothesis: Polymorphisms influence the efficacy and toxicity of specific Pulmonary Arterial Hypertension therapy as well as development/severity of PAH via their effect on PA remodeling, drug response, or metabolism.
This study requires a one time 8.5 ml blood sample and clinical data to be obtained at initiation of therapy, 4 months after initiation of therapy and 12 months after initiation of therapy.
Detailed Description
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Aim 1: Determine in Pulmonary Arterial Hypertension (the relationship between known disease-specific polymorphisms (Serotonin transporter gene and PAI HindIII) and variants in BMPR2 and SMAD4 with several well-defined clinical efficacy endpoints of sitaxsentan, bosentan, and ambrisentan therapy.
Aim 2: Determine in Pulmonary Arterial Hypertension the relationship between existing potentially "therapy-specific" polymorphisms in the ET-1, ETAR, ETBR, NPR-C, prostacyclin receptor and prostacyclin synthase with several well-defined clinical efficacy endpoints of sitaxsentan, bosentan, and ambrisentan therapy.
Aim 3: Characterize the relationship between any treatment effect, these polymorphisms and PAH severity, using either clinical data or clinical surrogates for disease activity.
\*\*\*This study was funded by the NIH from 2005 - 2009. In August 2009 a no-cost extension was granted and this study continued until the end of July 2010. Currently the study is still active and does still have several active sites participating; however, the study is funded by the internal institution and there is no contributing federal funding.\*\*\*
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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Group 1
GROUP 1
1. Patients have to be currently enrolled or previously enrolled in STRIDE FPH01, FPH01-XC FPH02, FPH02x, FPH03, FPH04 or FPH06.
2. WHO Group 1 Pulmonary arterial Hypertension: Idiopathic, Familial, Associated with (APAH) Collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, Drugs and toxins (e.g., anorexigens, rapeseed oil, L-tryptophan, methamphetamine, and cocaine), other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy) Associated with significant venous or capillary involvement, Pulmonary veno-occlusive disease, Pulmonary-capillary hemangiomatosis.
Sitaxsentan
Sitaxsentan sodium 100 mg tablet every morning
Group 2
Group 2
1. Patients currently receiving bosentan or ambrisentan OR who have previously received bosentan or ambrisentan for greater than 4 (four) months.
2. WHO Group 1 Pulmonary Arterial Hypertension: Idiopathic, Familial, Associated with (APAH), collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, drugs and toxins (e.g., anorexigens, rapeseed oil, L-tryptophan, methamphetamine, and cocaine), other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, or splenectomy), associated with significant venous or capillary involvement, pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis.
Bosentan, Ambrisentan
Bosentan 125 mg tablet twice daily Ambrisentan 5-10 mg tablet once daily
Interventions
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Sitaxsentan
Sitaxsentan sodium 100 mg tablet every morning
Bosentan, Ambrisentan
Bosentan 125 mg tablet twice daily Ambrisentan 5-10 mg tablet once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients have to be currently enrolled or previously enrolled in STRIDE FPH01, FPH01-XC FPH02, FPH02x, FPH03, FPH04 or FPH06.
* WHO Group 1 Pulmonary Arterial Hypertension: Idiopathic, Familial, Associated with (APAH) Collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, Drugs and toxins (e.g., anorexigens, rapeseed oil, L-tryptophan, methamphetamine, and cocaine), other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy) Associated with significant venous or capillary involvement, Pulmonary veno-occlusive disease, Pulmonary-capillary hemangiomatosis.
GROUP 2
* Patients currently receiving bosentan or ambrisentan OR who have previously received bosentan or ambrisentan for greater than 4 (four) months.
* WHO Group 1 Pulmonary Arterial Hypertension: Idiopathic, Familial, Associated with (APAH), collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, drugs and toxins (e.g., anorexigens, rapeseed oil, L-tryptophan, methamphetamine, and cocaine), other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, or splenectomy), associated with significant venous or capillary involvement, pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis.
Exclusion Criteria
* Not enrolled in the Encysive Pharmaceutical's STRIDE study(sitaxsentan).
* Known infectious disease (HIV, Hepatitis).
GROUP 2
* Never enrolled in the STRIDE study for sitaxsentan patients.
* Not currently or previously on bosentan or ambrisentan.
* Patients who were previously on bosentan or ambrisentan must have been on bosentan or ambrisentan for greater than 4 months.
* Known infectious disease (HIV, Hepatitis).
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Baylor College of Medicine
OTHER
Emory University
OTHER
University of Chicago
OTHER
Johns Hopkins University
OTHER
Tufts Medical Center
OTHER
Sir Mortimer B. Davis - Jewish General Hospital
OTHER
London Health Sciences Centre
OTHER
University of Maryland, College Park
OTHER
University of California, San Francisco
OTHER
University of Calgary
OTHER
Chest Medical Associates
UNKNOWN
Columbia University
OTHER
Lung Diagnostics, Ltd.
UNKNOWN
Duke University
OTHER
University of California, Los Angeles
OTHER
Latter Day Saints Hospital
OTHER
Louisiana State University Health Sciences Center in New Orleans
OTHER
Massachusetts General Hospital
OTHER
Mayo Clinic
OTHER
Medical College of Wisconsin
OTHER
Southeastern Lung Care
UNKNOWN
Suncoast Lung Center
UNKNOWN
Children's Hospital Colorado
OTHER
University Hospitals Cleveland Medical Center
OTHER
University of Colorado, Denver
OTHER
University of Michigan
OTHER
University of Pittsburgh Medical Center
OTHER
University of Southern California
OTHER
The University of Texas Medical Branch, Galveston
OTHER
Vanderbilt University
OTHER
Wayne State University
OTHER
Ohio State University
OTHER
University of Alabama at Birmingham
OTHER
Washington University School of Medicine
OTHER
Sentara Norfolk General Hospital
OTHER
University of Texas Southwestern Medical Center
OTHER
Bay Area Chest Physicians
OTHER
West Penn Allegheny Health System
OTHER
Responsible Party
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Dawnmarie DeFazio
Professor of Medicine, Drexel University College of Medicine, James Magovern Chair for Cardiovascular Research Director and Section Head Advanced Heart Failure, Transplant, Mechanical Circulatory Support and Pulmonary Hypertension Programs
Principal Investigators
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Raymond L Benza, MD
Role: PRINCIPAL_INVESTIGATOR
Allegheny General Hospital/Allegheny-Singer Research Institute of West Penn Allegheny Health System
Locations
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Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Countries
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Related Links
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Pulmonary Hypertension Association website
Other Identifiers
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RC #4590
Identifier Type: OTHER
Identifier Source: secondary_id
RC-4590
Identifier Type: -
Identifier Source: org_study_id