NCT06861075 CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound
| NCT ID | NCT06861075 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-16 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-04-16 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients ≥ 18 years * Suspected portal hypertension associated with cirrhosis (of any aetiology) as defined by: 1. 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 2. and/or the presence of a radiological sign of portal hypertension : Portosystemic shunts: rectal varices, splenorenal shunts, repermeabilization of the umbilical vein. 3. and/or splenic elasticity \> 50 kPa. * Patients naive to treatment with cardioselective beta blockers * Affiliated to french health insurance system Exclusion Criteria: * 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 * Presence of severe acute alcoholic hepatitis (Madrey score ≥ 32). * Current hepatic encephalopathy ≥ Grade 2. * Ongoing hepato-renal syndrome. * Profuse clinical ascites (only if it interferes with the feasibility of echo-endoscopy). * History of oesophageal varices rupture. * Hepatocellular carcinoma active or in remission for less than six months. * 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.). * Patients taking antiaggregants (except acetylsalicylic acid) or anticoagulants for embologenic CA/FA. * Severe stage 4 chronic renal insufficiency or stage 5 end-stage renal insufficiency (clearance \< 30 mL/min). * 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 currently taking part in another clinical research protocol. * Patients who do not understand French language.
Contact & Investigator
Armando Abergel
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT06861075 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06861075 currently recruiting?
Yes, NCT06861075 is actively recruiting participants. Contact the research team at promo_internet_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT06861075 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France, Clermont-Ferrand, France.
Who is sponsoring the NCT06861075 clinical trial?
NCT06861075 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Armando Abergel at University Hospital, Clermont-Ferrand. The trial plans to enroll 30 participants.