Tests carvedilol to lower portal pressure in people with cirrhosis
Tests carvedilol in adults with cirrhosis to lower high liver blood pressure.
Key facts
- Who runs it
- University Hospital, Clermont-Ferrand
- Where
- Clermont-Ferrand, FranceSee the 2 sites
- Trial code
- Registry title
- CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 16 Apr 2025
- Expected to end
- 1 Apr 2028
- Type of study
- Interventional
- Treatments tested
- Carvedilol
- Record updated
- 22 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with suspected portal hypertension from cirrhosis who have never taken cardioselective beta blockers. It tests carvedilol 12.5 mg daily for one month.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Suspected portal hypertension linked to cirrhosis of any cause, shown by Baveno VII criteria (liver stiffness, platelets, or oesophageal varices with high bleeding risk), and/or X-ray signs of portal hypertension, and/or spleen stiffness above 50 kPa.
- Earlier treatment
- Must never have been treated with cardioselective beta blockers.
Main reasons for not taking part
- Cannot take beta blockers (for example severe heart failure, severe slow heartbeat, severe low blood pressure, severe asthma or COPD)
- History of oesophageal varices rupture
- Liver cancer that is active or in remission for less than six months
- Pregnant or breast-feeding women, or women planning pregnancy
- Severe kidney failure (clearance under 30 mL/min)
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- Patients ≥ 18 years
- Suspected portal hypertension associated with cirrhosis (of any aetiology) as defined by:; Baveno VII criteria :; Liver stiffness ≥ 25 kPa Or Liver stiffness between 20 and 25 kPa and platelets < 150 G/L Or Liver stiffness between 15 and 20 kPa and platelets < 110 G/L Or Liver stiffness > 20 kPa and/or platelets < 150 G/L in patients with cirrhosis due to NASH; Or Oesophageal varices with high risk of bleeding :; Size > 5 mm (stage 2 or 3) Or Size ≤ 5 mm and red spots Or Size ≤ 5 mm and Child-Pugh score C; and/or the presence of a radiological sign of portal hypertension : Portosystemic shunts: rectal varices, splenorenal shunts, repermeabilization of the umbilical vein; and/or splenic elasticity > 50 kPa
- Patients naive to treatment with cardioselective beta blockers
- Affiliated to french health insurance system
Who cannot take part
- Absolute contraindications to beta blockers :; hypersensitivity to the active substance (carvedilol) or to any of the excipients listed in section 6.1 of the summary of product characteristics; patients with severe decompensated heart failure, with signs of fluid overload (oedema, ascites, pulmonary stasis rales), and/or requiring treatment with a positive inotrope or venous vasodilator; second and third-degree atrioventricular blocks (unless presence of a permanent pacemaker); severe bradycardia (≤ 50 bpm); cardiac sinus disease (including sino-auricular block); severe hypotension (systolic pressure < 85 mm Hg); cardiogenic shock; severe asthma, severe chronic obstructive pulmonary disease, history of severe bronchospasm; history of anaphylactic reaction; Raynaud's phenomenon; peripheral circulatory disorder: severe obliterative arterial disease of the lower limbs; association with cimetidine; association with class I antiarrhythmics except lidocaine; pulmonary arterial hypertension
- Patients currently taking part in another clinical research protocol
- Presence of severe acute alcoholic hepatitis (Madrey score ≥ 32)
- Ongoing hepato-renal syndrome
- History of oesophageal varices rupture
- Active or resolved portal vein thrombosis for less than six months
- History of digestive surgery that does not allow the porto-systemic gradient to be measured using echo-endoscopy (gastrectomy, by-pass, etc.)
- Severe stage 4 chronic renal insufficiency or stage 5 end-stage renal insufficiency (clearance < 30 mL/min)
- Current hepatic encephalopathy ≥ Grade 2
- Profuse clinical ascites (only if it interferes with the feasibility of echo-endoscopy)
- Hepatocellular carcinoma active or in remission for less than six months
- Patients taking antiaggregants (except acetylsalicylic acid) or anticoagulants for embologenic CA/FA
- Pregnant or breast-feeding women, or those planning to become pregnant*; *A pregnancy test will be carried out for women of childbearing potential, and the investigator will ensure that effective contraception is in place while Carvedilol is being taken and for 5 half-lives after stopping it
- Patients protected by law (under guardianship, curatorship or safeguard of justice) or deprived of their freedom
- Patients who do not understand French language
Where in France
- Chu Estaing Medecine Digestive Et HepatobiliaireClermont-Ferrand, FranceContact: Armando ABERGELTaking people
- Lise LaclautreClermont-Ferrand, FranceContact: Armando Abergel (principal investigator)Not yet recruiting
About the trial
What the trial wants to find out
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.
The group in the trial
- Single armTreatment being tested
All patients will receive Carvedilol per os (dose escalation up to 12.5 mg per day).
Treatment: Carvedilol
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound
- Plain-language title
- Tests carvedilol to lower portal pressure in people with cirrhosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 22 September 2025