Natural History Study of Biomarkers in Pulmonary Arterial Hypertension

This study aims to understand how pulmonary arterial hypertension (PAH), which is high blood pressure in the lungs, progresses over time. Researchers want to find new ways to classify how severe PAH is by looking at novel tests, such as inflammatory markers or special heart MRI scans. They will compare these tests to how far people can walk in six minutes. The study includes people aged 18 to 100 years old who have confirmed or suspected PAH, as well as healthy volunteers. The goal is to discover new targets for future treatments. The study status is currently unclear.

Study design
This is an observational study planning to enroll 270 participants. It compares people with PAH to healthy volunteers.
What's involved
Participants with PAH will have periodic visits to the National Institutes of Health Clinical Center. The specific procedures and tests are not detailed.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, which measures how well novel tests classify disease severity, will be assessed at 10 years.

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NCT01730092

Natural History Study of Biomarkers in Pulmonary Arterial Hypertension

Recruiting
Not specifiedAges 18+Observational
National Institutes of Health Clinical Center (CC)
~270 participants
Updated 2026-09-16 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 10 years
Pulmonary Disease
Pulmonary Hypertension

NCT01730092

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Michael A Solomon, M.D. · PRINCIPAL_INVESTIGATOR · National Institutes of Health Clinical Center (CC)

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Eligibility criteria

Inclusion

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).
Must be eligible for MRI and Gadolinium Based MRI studies
Must be eligible for CT and Iodine Based Contrast CT studies

Exclusion

Pregnant or breastfeeding women (all women of childbearing potential will be required to have a screening urine or blood pregnancy test)
Age less than 18 years
Inability to provide informed written consent for participation in the study
Current pregnancy or breastfeeding (All women of childbearing potential will be required to have a screening urine or blood pregnancy test)
Electrocardiographic evidence of clinically relevant heart disease
Symptoms of coronary or cardiac insufficiency
More than one major risk factor for coronary artery disease (excluding age and sex)
Obesity (defined as a body mass index \> 30 kg/m\^2)
History of underlying conditions/risk factors associated with pulmonary hypertension such as collagen vascular disease, HIV infection, use of appetite suppressants, chronic liver disease or cirrhosis of the liver, chronic thromboembolic disease, congenital heart defects, hypoxemia and/or significant pulmonary parenchymal disease
Systemic hypertension that is not well controlled (i.e. blood pressure at the time of screening \>140/90 mmHg in adults \< 60 years old or \>150/90 mmHg in adults 60 years or older) on medications. Subjects taking \> 2 anti-hypertensive medications will be excluded irrespective of their current blood pressure at time of screening
Anemia, thrombocytopenia or coagulopathy
Renal insufficiency (defined as an estimated glomerular filtration rate of \< 60 mL/min/1.73m\^2 of body surface area)
Active tobacco use (\> 6 months) in the past ten years, any tobacco use within 3 months prior to the screening evaluation or any tobacco use prior to completion of the study
Inability to provide informed written consent for participation in the study
History of recreational drug use with the exception of marijuana (as long as marijuana use was \> 3 months from the time of study screening).
Volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer.
  • 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.10 years

    Compare outcomes in PAH subjects with controls