NCT06861075

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for entry study. \- Inclusion visit (day 1) includes an oesogastroduodenal fibroscopy (OGDF) followed by an endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement, an electrocardiogram, a clinical examination, and a first intake of study treatment : Carvedilol 3.125 mg. Carvedilol, day 2 to day 8: 6.25 mg/day (3.125 mg twice a day). - Visit 2 (day 6 +/- 2 days): clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram if indicated, assessment of compliance with study treatment. Carvedilol, day 9 to day 90 (end of study visit): 12.5 mg/day (6.25 mg twice a day). \- Visit 3 (day 13 +/- 2 days): clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram if indicated, assessment of compliance with study treatment. Carvedilol will be continued at the dose of 12.5 mg/day, on a long-term basis. - Visit 4 (day 30-45): OGDF followed by an EUS-PPG measurement, clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram if indicated, assessment of compliance with study treatment. Carvedilol will be continued at the dose of 12.5 mg/day. \- Visit 5 (day 90 +/- 7 jours), end of study visit: clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram, assessment of compliance with study treatment. Treatment with Carvedilol will be prescribed by a cardiologist and continued at the dose of 12.5 mg/day. Follow-up of the patient according to standard practice. NB: an adaptation of the dose of Carvedilol may be considered according to tolerability, throughout the study.

Conditions

• Cirrhosis
• Portal Hypertension Related to Cirrhosis

Interventions

Type	Name	Description
DRUG	Carvedilol	Carvedilol per os, day 1:3.125 mg once, day 2 to day 8: 6.25 mg/day (3.125 mg twice a day), day 9 to day 90 (end of study visit): 12.5 mg/day (6.25 mg twice a day). After the end of the study, treatment with Carvedilol will be prescribed by a cardiologist and continued at the dose of 12.5 mg/day. The follow-up of the patient will be then done according to the standard practice.

Timeline

• Start date: 2025-04-16
• Primary completion: 2028-03-01
• Completion: 2028-04-01
• First posted: 2025-03-06
• Last updated: 2025-09-22

Locations

2 sites across 1 country: France