Pulmonary Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For people with confirmed or suspected pulmonary arterial hypertension (PAH):

• Adults aged 18 or older who have been diagnosed with, or are suspected to have, a specific type of high blood pressure in the lungs called Group 1 pulmonary hypertension
• People whose heart catheterisation results show: lung artery pressure above 25 mmHg at rest, a specific pressure reading in the lungs below 15 mmHg (or a related heart pressure below 12 mmHg), and significant resistance to blood flow in the lungs (confirm with trial site for exact values)
• People who have not yet had a full diagnostic workup may still be considered, as testing may be completed as part of the trial if clinically appropriate
• People of any race or sex are eligible to be considered

For healthy control participants (comparison group):

• Healthy men or women whose age and sex match those of a PAH patient enrolled in the trial
• People who are eligible to undergo MRI scans, including those using a contrast dye called gadolinium (confirm with trial site)
• People who are eligible to undergo CT scans, including those using an iodine-based contrast dye (confirm with trial site)

Who may not be able to join:

For people with PAH:

• Women who are currently pregnant or breastfeeding (a pregnancy test will be required for women who could potentially be pregnant)
• People under 18 years of age
• People who are not able to read and sign a written consent form

For healthy control participants:

• Women who are currently pregnant or breastfeeding (a pregnancy test will be required for women who could potentially be pregnant)
• People whose ECG (heart tracing) shows signs of a significant heart condition
• People who have symptoms suggesting reduced blood flow to the heart
• People who have more than one major risk factor for blocked heart arteries (not counting age or sex)
• People with a body mass index (BMI) above 30 (a measure of weight relative to height)
• People with a history of conditions linked to pulmonary hypertension, such as certain autoimmune diseases, HIV, use of weight-loss medications, chronic liver disease, blood clots in the lungs, heart defects present from birth, low oxygen levels, or significant lung disease
• People with poorly controlled high blood pressure at the time of screening — specifically, blood pressure above 140/90 mmHg for adults under 60, or above 150/90 mmHg for adults 60 and older — or people taking more than two blood pressure medications, regardless of their current readings
• People with low red blood cell counts, low platelet counts, or blood clotting problems
• People with reduced kidney function (a kidney filtration rate below 60 mL/min/1.73m²)
• People who have used tobacco products for more than 6 months at any point in the past ten years, within 3 months before screening, or at any time before completing the study
• People with a history of recreational drug use, except marijuana used more than 3 months before screening
• People who, in the opinion of the study investigators, have any condition that could affect study results or their own safety
• People who are not able to read and sign a written consent form

For all participants — MRI-related exclusions:

• People with an implanted heart pacemaker or defibrillator
• People with cochlear (inner ear) implants
• People with metal fragments in or around the eyes
• People with embedded shrapnel
• People with metal clips used to treat a brain aneurysm
• People with an implanted nerve stimulator
• People with any other implanted device that cannot safely be used near an MRI machine
• People whose doctor considers them too unwell to tolerate an MRI scan (for example, unstable chest pain or severe breathlessness at rest)
• People who would need sedation to undergo an MRI
• People who cannot physically enter or remain in the MRI scanner (for example, due to severe obesity, claustrophobia, severe back pain, or movement difficulties)

For MRI scans using gadolinium contrast dye (all participants):

• People who have had a severe allergic reaction to gadolinium contrast dye even after being given allergy-prevention medications
• People with chronic kidney disease (kidney filtration rate below 60 mL/min/1.73m²)

For CT scans — general exclusions (all participants):

• People who cannot physically enter or remain in the CT scanner (for example, due to severe obesity or claustrophobia)

For CT scans using iodine-based contrast dye (all participants):

• People with a blood creatinine level above 1.4 mg/dL (a marker of kidney function)
• People with a history of a bone marrow condition called multiple myeloma
• People who have taken metformin-containing diabetes medications within 24 hours before the contrast dye is given
• People who have had a severe allergic reaction to CT contrast dye even after being given allergy-prevention medications

Important: Always verify eligibility with the trial site directly before applying.