Actively Recruiting
CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound
Led by University Hospital, Clermont-Ferrand · Updated on 2025-09-22
30
Participants Needed
2
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the efficacy after one month of treatment with Carvedilol (12.5 mg daily) in primary prophylaxis of digestive haemorrhage due to portal hypertension in cirrhosis, by endoscopic ultrasound-guided portal pressure gradient measurement.
CONDITIONS
Official Title
CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Suspected portal hypertension linked to cirrhosis of any cause, defined by Baveno VII criteria or presence of esophageal varices with high bleeding risk
- Presence of radiological signs of portal hypertension such as portosystemic shunts
- Splenic elasticity greater than 50 kPa
- Patients who have never been treated with cardioselective beta blockers
- Affiliated with the French health insurance system
You will not qualify if you...
- Allergy to Carvedilol or any of its ingredients
- Severe decompensated heart failure with fluid overload or requiring certain heart medications
- Second or third-degree atrioventricular heart block unless having a permanent pacemaker
- Severe slow heart rate (50 bpm or less)
- Cardiac sinus node disease (including sino-auricular block)
- Severe low blood pressure (systolic less than 85 mm Hg)
- Cardiogenic shock
- Severe asthma, chronic obstructive pulmonary disease, or history of severe bronchospasm
- History of anaphylactic reaction
- Raynaud's phenomenon
- Severe peripheral arterial disease of the lower limbs
- Use of cimetidine or certain class I antiarrhythmic drugs except lidocaine
- Pulmonary arterial hypertension
- Severe acute alcoholic hepatitis (Madrey score 32 or higher)
- Hepatic encephalopathy grade 2 or higher
- Ongoing hepato-renal syndrome
- Profuse clinical ascites preventing echo-endoscopy
- History of esophageal varices rupture
- Active or recent hepatocellular carcinoma (less than 6 months remission)
- Active or recent portal vein thrombosis (less than 6 months)
- Digestive surgery preventing porto-systemic gradient measurement by echo-endoscopy
- Use of antiaggregants or anticoagulants except aspirin for embolic conditions
- Severe or end-stage chronic kidney disease (clearance less than 30 mL/min)
- Pregnant or breastfeeding women or those planning pregnancy without effective contraception
- Patients under legal protection or deprived of liberty
- Participation in another clinical research study
- Inability to understand French language
AI-Screening
AI-Powered Screening
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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
CONTACT
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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