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Active Clinical Trials

PAH BIOBANK

Active
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Supported by the National, Heart, Lung and Blood Institute of the National Institutes of Health under award R24HL105333
Contact: 

For more information, please contact Priscilla Correa at 412-359-3708 or Priscilla.Correa@ahn.org

National Biological Sample and Data Repository for Pulmonary Arterial Hypertension

Purpose: 

The specific purpose of this study is to establish a national biorepository of biological samples and genetic data of patients with WHO Group 1 PAH. As an Investigator-Initiated Resource-Related Research Project (R24) sponsored by NHLBI, no hypothesis driven science is proposed for this project. The function of this biorepository is to collect the samples from the patients, generate genetic data, and widely promote and distribute the samples/data to the scientific community. Investigators requesting samples will submit requests and proposed uses of the samples which will be reviewed by a committee comprised of investigators from several of the enrolling centers.

The intended participants are those meeting the criteria of the diagnosis of WHO Group 1 PAH. These criteria are: mean pulmonary artery pressure (PAP) >25 mm Hg at rest (30 mm Hg with exercise), pulmonary capillary wedge pressure (PCWP) ≤ 18 mm Hg (traditional is PWCP ≤ 15 mm Hg), and pulmonary vascular resistance (PVR) ≥ 240 dynes·sec·cm-5. We will enroll no less than 500 patients per year over the course of the next five years. We are recruiting both prevalent and incident patients for the biorepository. Incident patients will be valuable if we are able to obtain biological samples prior to the onset of therapy for the disorder. Any incident patients for whom this is possible will also be sampled a second time six to twelve months (or as clinic visits allow) post therapy to enable the study of changes in proteins and biomarkers with treatment. No controls will be recruited. Biological relatives’ samples will be collected from CCHMC and Children’s Hospital Colorado on a small subset of the WHO Group 1 PAH subjects who are participating in the Biobank. If a sample collected from a patient is determined to not be useable, additional samples may be requested from the patient. Children under the age of 18 are eligible to participate with proper assent (age 11 and greater) and parental consent. While children will not be excluded from participation in the study, their participation is expected to be less than 7% of the subject population. The average age of onset of IPAH is mid 20’s/early 30’s. Thus, the age of onset of PAH lowers the expected number of children to enroll.

Any participants determined to be vulnerable (children, pregnant women, neonates) will undergo additional safeguards to protect these subjects. Assent from the child in addition to consent from one parent will be obtained from all individuals aged 11 to 18.