Pharmacogenomics in Pulmonary Arterial Hypertension

Summary

Our goal is to determine clinically in Pulmonary Arterial Hypertension patients if associations exist between the efficacy and toxicity of sitaxsentan, bosentan, and ambrisentan and several gene polymorphisms in several key disease-specific and therapy specific genes. Also characterized is the relationship between these polymorphisms and the severity of Pulmonary Arterial Hypertension using either baseline hemodynamic or clinical surrogates for disease severity.

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.

Conditions

• Pulmonary Arterial Hypertension
• Pulmonary Hypertension
• PAH WHO Group I

Interventions

DRUG

Sitaxsentan

Sitaxsentan sodium 100 mg tablet every morning

DRUG

Bosentan, Ambrisentan

Bosentan 125 mg tablet twice daily Ambrisentan 5-10 mg tablet once daily

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Baylor College of Medicine

  collaborator OTHER

• Emory University

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Tufts Medical Center

  collaborator OTHER

• Sir Mortimer B. Davis - Jewish General Hospital

  collaborator OTHER

• London Health Sciences Centre

  collaborator OTHER

• University of Maryland, College Park

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• Chest Medical Associates

  collaborator UNKNOWN

• Columbia University

  collaborator OTHER

• Lung Diagnostics, Ltd.

  collaborator UNKNOWN

• Duke University

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Latter Day Saints Hospital

  collaborator OTHER

• Louisiana State University Health Sciences Center in New Orleans

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• Southeastern Lung Care

  collaborator UNKNOWN

• Suncoast Lung Center

  collaborator UNKNOWN

• Children's Hospital Colorado

  collaborator OTHER

• University Hospitals Cleveland Medical Center

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• The University of Texas Medical Branch, Galveston

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Wayne State University

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Sentara Norfolk General Hospital

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Bay Area Chest Physicians

  collaborator OTHER

• West Penn Allegheny Health System

  lead OTHER

Principal Investigators

• Raymond L Benza, MD · Allegheny General Hospital/Allegheny-Singer Research Institute of West Penn Allegheny Health System

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-07-31

Primary Completion

2012-07-31

Completion

2012-07-31

Countries

• United States

Study Locations