Clinical Trial: Identification of Genetic Markers for Cardiopulmonary Diseases (Genotype)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Identification of Genetic Markers for Cardiopulmonary Diseases

Brief Summary: This study is designed to investigate whether an association exists between certain genes/protein levels and the development of various cardiopulmonary diseases. It is hoped that this project will provide valuable insight into the understanding of these diseases.

Detailed Summary:

There are two main groups of participants in this trial:

Group 1: Patients that are enrolled in either or both of previous studies: X980515002 study (Identification of Genetic Markers for Primary Pulmonary Hypertension) and or X030403017 study (Pulmonary Arterial Hypertension (PAH) Database)

Group 2: Participants with the diagnosis of any of the previously listed Cardiopulmonary Diseases who are ≥15 years of age

Group 1: For those patients who have had blood samples drawn as a result of participating in the current protocol, Identification of Genetic Markers for Primary Pulmonary Hypertension study (X980515002), we would like to use their previously obtained blood and continue to draw samples (12mL; less than 3 tablespoons) ONLY if they change disease therapies. With each disease therapy change, blood will be drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. These current X980515002 participants WILL sign a consent form to participate in this new trial. As for the X980515002 expired patients, we would like to use the previously obtained data ONLY in part for this study that was collected as a result of the X980515002 study.

For those patients who participated in Pulmonary Arterial Hypertension (PAH) Database study (X030403017), these participants WILL also sign a consent form to participant in this new trial. We would like to use the previously obtained data from the X030403017 in part with this study. With each disease therapy change, a 12mL (less than 3 teaspoons) blood sample will be drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. As for the X030403017 expired patients, we would like to use the previously obtained data in part for this study that
Sponsor: University of Alabama at Birmingham

Current Primary Outcome: Changes in NYHA WHO Functional Class,right and left heart catheterization measurements, echocardiograms, 6MWT, laboratory values, electrocardiograms, x-ray's, MRI's, CT Scans, Pulmonary Function Tests, and Ventilation Perfusion Scans will be assessed. [ Time Frame: 10 years ]

Original Primary Outcome: Information learned may serve to develop new methods of predicting response to therapy in various cardiopulmonary diseases to improve therapy in the future. [ Time Frame: 10 years ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Alabama at Birmingham

Dates:
Date Received: February 5, 2008
Date Started: January 2008
Date Completion:
Last Updated: January 7, 2016
Last Verified: January 2016