National Biological Sample and Data Repository for Pulmonary Arterial Hypertension
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 12-000594
Sponsor Protocol Number: 12-000594
About this study
The specific purpose of this study is to establish a national biorepository of biological samples and genetic data of patients with the World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH). The function of this biorepository is to collect the samples from the patients, generate the proposed 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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)
- Pulmonary vascular resistance (PVR) ≥240 dynes·sec·cm-5.
- Children under the age of 18 are eligible to participate with proper assent (age 7 and greater) and parental consent.
Exclusion Criteria:
- Only subjects diagnosed with WHO Group 1 PAH will be enrolled.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Charles Burger, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available