Actively Recruiting
CARPEUS Study: Effect of Carvedilol on Portal Pressure Gradient Using Endoscopic Ultrasound in Cirrhosis
Led by University Hospital, Clermont-Ferrand · Updated on 2025-09-22
30
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of Carvedilol in preventing digestive bleeding caused by portal hypertension in people with cirrhosis. The study aims to measure how well Carvedilol lowers the pressure gradient in the portal vein system using a specialized ultrasound technique. This investigation is conducted in a clinical setting to assess changes after one month of treatment. Participants will receive Carvedilol orally starting with 3.125 mg on the first day, increasing to 6.25 mg daily from day 2 to day 8, then 12.5 mg daily from day 9 to day 90. Several study visits include clinical exams, blood pressure and pulse monitoring, electrocardiograms if needed, and assessments of treatment adherence. Endoscopic ultrasound measurements will be done at the beginning and around day 30 to evaluate the portal pressure. Throughout the study, participants will have regular check-ups to monitor their health, possible side effects, and response to the medication. Researchers will track any digestive hemorrhages occurring within three months and review heart and vital sign data. The total participation lasts about three months, with continued treatment and follow-up care planned according to standard medical practice after the study ends.
CONDITIONS
Brief Title
CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Suspected portal hypertension with cirrhosis of any cause based on specific clinical or radiological criteria
- No previous treatment with cardioselective beta blockers
- Affiliated with the French health insurance system
You will not qualify if you...
- Allergy to Carvedilol or its ingredients
- Severe heart problems including decompensated heart failure, certain heart blocks, severe bradycardia, cardiac sinus disease, severe hypotension, cardiogenic shock
- Severe respiratory diseases like severe asthma or COPD
- History of severe allergic reactions or Raynaud's phenomenon
- Severe peripheral circulatory issues
- Concurrent use of certain medications like cimetidine or class I antiarrhythmics except lidocaine
- Pulmonary arterial hypertension
- Severe acute alcoholic hepatitis
- Moderate to severe hepatic encephalopathy
- Ongoing hepato-renal syndrome
- Severe ascites affecting echo-endoscopy
- History of esophageal varices rupture
- Recent or active hepatocellular carcinoma or portal vein thrombosis
- Prior digestive surgeries preventing portal pressure measurement
- Use of antiaggregants or anticoagulants (except aspirin) for embolic conditions
- Severe kidney failure with clearance below 30 mL/min
- Pregnant, breastfeeding, or planning pregnancy without effective contraception
- Legal protection status or deprivation of freedom
- Participation in another clinical research study
- Inability to understand French language
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Approximately 90 days
Participants take Carvedilol with dose escalation from 3.125 mg on Day 1, to 6.25 mg/day from Day 2 to Day 8, and 12.5 mg/day from Day 9 to Day 90. They undergo clinical examinations and monitoring for side effects and compliance throughout this period.
5 visits (in-person) on Day 1, Day 6 ± 2 days, Day 13 ± 2 days, Day 30-45, and Day 90 ± 7 days
Duration - Indefinite, according to routine care
Participants continue Carvedilol treatment prescribed by a cardiologist and are followed according to standard medical practice after the study ends.
Visits as per standard practice
Trial Site Locations
Total: 2 locations
1
Lise Laclautre
Clermont-Ferrand, France, 63000
Not Yet Recruiting
2
Chu Estaing Medecine Digestive Et Hepatobiliaire
Clermont-Ferrand, France, 63003
Actively Recruiting
Research Team
L
Lise Laclautre
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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