CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Estaing Medecine Digestive Et Hepatobiliaire
RECRUITING
Clermont-ferrand
Lise Laclautre
NOT_YET_RECRUITING
Clermont-ferrand
Contact Information
Primary
Lise Laclautre
promo_internet_drci@chu-clermontferrand.fr
+33473754963
Time Frame
Start Date: 2025-04-16
Estimated Completion Date: 2028-04-01
Participants
Target number of participants: 30
Treatments
Experimental: Single arm
All patients will receive Carvedilol per os (dose escalation up to 12.5 mg per day).
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov