Hypertension Trial, Recruiting

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

Who might be able to join this trial:

• People aged 18 to 75 years old
• People diagnosed with high blood pressure in the liver's main vein (portal hypertension) caused by liver scarring (cirrhosis), and who have had bleeding from swollen veins in the digestive tract, fluid around the lungs caused by liver disease, or persistent fluid build-up in the abdomen that is hard to treat
• People whose liver is still functioning well enough, as measured by specific liver scoring systems (MELD score of 13 or below, or Child-Pugh score of 18 or below)
• People with a platelet count of at least 20×10⁹ per litre (a basic blood cell measure that helps with clotting)
• People, or their legal guardians, who are willing to take part, sign a consent form, and attend all required follow-up visits

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant during the trial
• People who have a large blood clot blocking more than half of the main liver vein, in a way that the investigators believe could affect outcomes after the procedure
• People who have already had certain procedures to treat complications of portal hypertension, such as TIPS, surgical shunts, or a procedure called RTO — although people who had RTO at least 8 weeks before signing the consent form may still be considered
• People who need to have, or have already had, their spleen removed
• People who have had, or are planning to have, a liver transplant
• People for whom the investigators determine it is not possible to create the required internal pathway between liver blood vessels
• People with cancer inside or outside the liver
• People with certain conditions that block blood flow from the liver, specifically Budd-Chiari syndrome or hepatic sinusoidal obstruction syndrome
• People with certain inherited bile duct conditions (Caroli disease) or blockages in the bile ducts
• People with a condition called polycystic liver disease (many fluid-filled sacs in the liver)
• People with a condition where the portal vein has become replaced by many small vessels (cavernous transformation)
• People with serious or hard-to-manage brain function problems related to liver disease, rated Grade 2 or above on a standard medical scale
• People with a bilirubin (a substance measured in blood) level above 51.3 μmol/L, unless the high level is due to a specific type of liver disease involving bile build-up
• People with significant blood-clotting problems, as measured by a specific blood test result (INR above 2.5)
• People with a resting systolic blood pressure below 80 mmHg (the top number in a blood pressure reading)
• People with serious leaking of a heart valve (tricuspid regurgitation) or heart failure causing fluid build-up in the body
• People who have had a heart attack in the past 3 months
• People with moderate to severe high blood pressure in the lungs, or severe lung complications related to liver disease
• People with an infection or widespread inflammation that is not under control
• People with severe kidney problems (measured by a specific blood marker above 199.5 μmol/L) or who need dialysis
• People known to be allergic to contrast dye used in imaging, or to any materials used in the trial device
• People with a history of epilepsy, mental illness, or significant difficulties with thinking and memory
• People whose life expectancy is estimated to be less than one year
• People who are currently taking part in another clinical trial for a drug or medical device that has not yet finished
• People whom the investigators determine are not suitable for any other reason (confirm with trial site)

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