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

Korábbi kezelés

• 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
• Patients currently taking part in another clinical research protocol.

Más betegség

• Presence of severe acute alcoholic hepatitis (Madrey score ≥ 32).
• Ongoing hepato-renal syndrome.
• History of oesophageal varices rupture.
• 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.).

Laborértékek

• Severe stage 4 chronic renal insufficiency or stage 5 end-stage renal insufficiency (clearance < 30 mL/min).

Egyéb

• Current hepatic encephalopathy ≥ Grade 2.
• Profuse clinical ascites (only if it interferes with the feasibility of echo-endoscopy).
• Hepatocellular carcinoma active or in remission for less than six months.
• Patients taking antiaggregants (except acetylsalicylic acid) or anticoagulants for embologenic CA/FA.
• Pregnant or breast-feeding women, or those planning to become pregnant*.
  • *A pregnancy test will be carried out for women of childbearing potential, and the investigator will ensure that effective contraception is in place while Carvedilol is being taken and for 5 half-lives after stopping it.
• Patients protected by law (under guardianship, curatorship or safeguard of justice) or deprived of their freedom.
• Patients who do not understand French language.

• 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