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

Recruiting now · Not applicable

Conditions studied: Cirrhosis, Portal Hypertension Related to Cirrhosis

In brief

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 facts

Study ID

NCT06861075

Run by

University Hospital, Clermont-Ferrand

People needed

30

Starts

2025-04-16

Expected to finish

2028-04-01

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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).

Where it is running

• Chu Estaing Medecine Digestive Et Hepatobiliaire — Clermont-Ferrand, France (enrolling)
• Lise Laclautre — Clermont-Ferrand, France

Full record on ClinicalTrials.gov

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