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SHAPE measurement for Portal Hypertension
This trial will study if the SHAPE algorithm can accurately estimate portal pressures in patients with various degrees of liver disease, if it can predict the development of ascites and other liver-related events, and if it can be used to monitor treatment response in patients with portal hypertension.
- Portal Hypertension
- Liver Disease
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You have severe, uncontrolled heart failure.You have had a recent bleeding in your brain.You had surgery within 24 hours before the study ultrasound.You have severe lung damage or a history of blood clots in the lungs.You have had blood clots in the veins around your liver or intestines.You have had severe liver-related brain problems in the past 3 months.You have unstable heart or lung problems.You are currently receiving chemotherapy or being treated for another primary cancer.You have had a severe allergic reaction to perflutren (PEG) or any other parts of Definity in the past.You are currently on life support or in a critical care unit.You have a condition with unstable blockage in your blood vessels (like crescendo angina).You have a heart rhythm problem that is not well controlled and keeps coming back.You have had a severe allergic reaction to eggs or egg products in the past.You were born with a heart problem.You have difficulty breathing due to a lung condition.You are planning to have a liver biopsy with measurements of hepatic venous pressure gradient (HVPG) taken.You have serious liver blood pressure problems and are getting regular check-ups for liver cancer.You have been diagnosed with portal hypertension and are starting treatment with non-selective β-blockers.You have serious liver-related issues and are scheduled for a procedure to check for swollen veins in your stomach or esophagus.
- Group 1: Reproducibility - Cohort 1
- Group 2: HCC monitoring - Cohort 2
- Group 3: New β-blockers - Cohort 3
- Group 4: Ccreening for varices - Cohort 4
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any open slots for patients who want to participate in this clinical trial?
"The clinicaltrial.gov website informs us that this study has completed recruitment for participants. This trial was posted on August 15th, 2020 and the last update was July 20th, 2022. There are 1058 other trials currently recruiting patients."
Has SHAPE measurement (Sonazoid ultrasoud contrast agent) received FDA approval?
"There is both efficacy and safety data from multiple Phase 3 trials available for SHAPE measurement, so it was given a score of 3."
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