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

NCT06861075 | Recruiting

• 2 other identifiers: AOI 2023 POINCLOUX2024-518302-41-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Cirrhosis; Portal Hypertension Related to Cirrhosis

Keywords

Carvedilol.; Portal hypertension in cirrhosis.; EUS-PPG measurement.

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with a reduction of at least 10% in the porto-systemic gradient

  Hemodynamic response (binary efficacy criterion), defined as a reduction of at least 10% in the echo-endoscopic portosystemic gradient compared with the baseline value measured at inclusion.

  One month after starting carvedilol.

Secondary Outcomes (2)

• Side-effects of beta blockers

  From enrollment to D90.

• Number of participants with digestive hemorrhage

  Within three months of starting Carvedilol.

Study Arms (1)

Single arm

EXPERIMENTAL

All patients will receive Carvedilol per os (dose escalation up to 12.5 mg per day).

Drug: Carvedilol

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.

Also known as: CARVEDILOL ARROW ® 6,25 mg

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

Lise Laclautre

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Chu Estaing Medecine Digestive Et Hepatobiliaire

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Fibrosis

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Armando Abergel

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963; promo_internet_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 6, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)