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

Sponsor
University Hospital, Clermont-Ferrand
Study ID
NCT06861075
Status
Recruiting
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Conditions

  • Cirrhosis
  • Portal Hypertension Related to Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carvedilol — DRUG
    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.

Study Details

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.

Key Dates

First listed
Mar 6, 2025
Start date
Apr 16, 2025
Status verified
Sep 2025
Primary completion
Mar 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm
    All patients will receive Carvedilol per os (dose escalation up to 12.5 mg per day).

Primary Outcome Measure

Percentage of participants with a reduction of at least 10% in the porto-systemic gradient [ Time Frame: One month after starting carvedilol. ]

Central Contacts

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