Actively Recruiting
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Led by National Institutes of Health Clinical Center (CC) · Updated on 2026-04-14
270
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed diagnosis of PAH with mean pulmonary artery pressure > 25 mmHg at rest
- Pulmonary capillary wedge pressure ≤ 15 mmHg or left ventricular end-diastolic pressure ≤ 12 mmHg
- Pulmonary vascular resistance > 3 Wood units
- Healthy volunteers matched by age and sex to PAH patients
- Ability to provide informed written consent
- Eligibility for MRI and CT contrast studies for healthy volunteers
You will not qualify if you...
- Pregnant or breastfeeding women
- Age under 18 years
- Inability to provide informed written consent
- Electrocardiographic evidence of significant heart disease in healthy volunteers
- Symptoms of coronary or cardiac insufficiency in healthy volunteers
- More than one major risk factor for coronary artery disease (except age and sex) in healthy volunteers
- Obesity (BMI > 30) in healthy volunteers
- History of diseases or risk factors linked to pulmonary hypertension in healthy volunteers
- Uncontrolled systemic hypertension in healthy volunteers
- Blood disorders such as anemia, thrombocytopenia, or coagulopathy
- Renal insufficiency (eGFR < 60 mL/min/1.73m2)
- Active tobacco use within past 6 months or any tobacco use within 3 months prior to screening
- History of recreational drug use except marijuana if last use > 3 months before screening
- Contraindications to MRI including implanted devices, metal fragments, severe claustrophobia, or inability to tolerate MRI
- History of severe allergic reaction to gadolinium or iodine contrast agents
- Chronic kidney disease affecting contrast study eligibility
- Serum creatinine > 1.4 mg/dL for CT contrast studies
- Use of metformin within 24 hours prior to contrast administration
- Any condition that may affect study safety or outcomes as judged by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
G
Grace M Graninger, R.N.
CONTACT
M
Michael A Solomon, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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