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Identification of Genetic Markers for Cardiopulmonary Diseases (Genotype)

Identification of Genetic Markers for Cardiopulmonary Diseases

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00616369
Acronym
Genotype
Enrollment
255
Registered
2008-02-15
Start date
2008-01-31
Completion date
2015-01-31
Last updated
2016-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

pulmonary hypertension, hypertension, cardiomyopathy, arrhythmias

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 description

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 was collected as a result of the X030403017 study. Group 2: After signing a consent form, these participants will have a 12mL (less than 3 teaspoons) blood sample drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. With each disease therapy change, the blood draws (12mL samples) will begin again at baseline and continue through the 3-4, 6-8, 12, and 24 month visits.

Interventions

None listed

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participants with the diagnosis of any of the previously listed Cardiopulmonary Diseases who are ≥15 years of age will be approached and offered the opportunity to participate in this study.

Design outcomes

Primary

MeasureTime frame
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.10 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026