Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Institutes of Health Clinical Center (CC)
About this trial
Background:
\- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. Some people have disease-associated PAH and some have PAH from an unknown cause. Researchers want to follow the natural history of all PAH patients to understand how PAH progresses in order to discover targets for future research into new treatments. To further identify treatment targets, they will compare healthy volunteers to patients with PAH.
Objectives:
\- To study the natural history of PAH.
Eligibility:
* Individuals at least 18 years of age who have PAH. * Healthy volunteers at least 18 years of age.
Design:
* Participants with PAH will have periodic visits to the National Institutes of Health Clinical Center. After the first visit, they will return in 6 months and then yearly or every other year for as long as the study continues. * The first visit will take up to 3 days. It will involve the following tests: * Physical exam and medical history * Blood and urine samples * Heart and lung function tests and imaging studies * Six-minute walk test * Questions about exercise and physical activity * Healthy volunteers will have only one visit to the Clinical Center, during which they will undergo screening tests, and complete many of the same tests as patients with PAH
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
mean pulmonary artery pressure of > 25 mmHg at rest,
pulmonary capillary wedge pressure of < 15 mmHg (or a left ventricular end-diastolic pressure of < 12 mmHg), and
pulmonary vascular resistance of > 3 Wood units (240 dyn s cm-5).
Pregnant or breastfeeding women (all women of childbearing potential will be required to have a screening urine or blood pregnancy test)
Trial population
primary clinical for PAH and community sample for controls
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
270 Participants
are grouped into 2 trial groupsGroup A: Healthy Volunteers
Group B: Pulmonary Arterial Hypertension Subjects
Trial outcomes
Primary outcomes
1
Examine whether any novel test (inflammatory markers or high resolution cardiac MRI), accurately classifies PAH subjects according to disease severity as assessed by their baseline 6-minute walk distance.
Compare outcomes in PAH subjects with controls
Time frame
10 yearsSponsors and contacts
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Source ClinicalTrials.gov