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Noninvasive SHAPE for Portal Hypertension
Study Summary
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have portal hypertension and am starting treatment with non-selective β-blockers.You have had a severe allergic reaction to eggs or food containing eggs in the past.You have a serious or terminal illness, or your condition is very unpredictable.I do not have severe, uncontrolled heart failure.I am 18 years old or older.I am not pregnant or nursing.I have respiratory distress syndrome.I have had a recent brain bleed.I am not on chemotherapy or need treatment for another cancer.I have high blood pressure in the lungs or unstable heart/lung conditions.I had surgery less than 24 hours before a planned ultrasound exam.I am scheduled for a liver biopsy to measure my liver pressure.I have severe emphysema, pulmonary vasculitis, or a history of blood clots in my lungs.I am capable of becoming pregnant and have a negative pregnancy test.I have serious portal hypertension and am being regularly checked for liver cancer.I have serious portal hypertension and need an endoscopy to check for varices.I haven't had severe liver-related brain issues in the last 3 months.I do not have unstable heart rhythm problems like frequent fast heartbeats.I was born with a heart defect.I have blood clots in the veins of my liver or abdomen.You have had a severe allergic reaction to perflutren (PEG) or any other parts of Definity.I have worsening chest pain due to heart artery blockage.I am mentally alert and can follow study instructions.
- Group 1: Ccreening for varices - Cohort 4
- Group 2: HCC monitoring - Cohort 2
- Group 3: Reproducibility - Cohort 1
- Group 4: New β-blockers - Cohort 3
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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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