Natural History Study of Biomarkers in Pulmonary Arterial Hypertension

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institutes of Health Clinical Center (CC)
Study ID
NCT01730092
Status
Recruiting
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Conditions

  • Pulmonary Disease
  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Study Details

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

Key Dates

Start date
Jul 15, 2013
Status verified
May 2026
Primary completion
Dec 31, 2030

Study Design

Enrollment
270 participants (estimated)

Arms

  • Arm: Healthy Volunteers
    Enroll up to 120 healthy volunteers, in order to obtain approximately 55 evaluable healthy volunteers matched to pulmonary arterial hypertension subjects for age and sex
  • Arm: Pulmonary Arterial Hypertension Subjects
    150 subjects with pulmonary arterial hypertension; male or female, age grater than or equal to 18 - 99 years

Primary Outcome Measure

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. [ Time Frame: 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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