Carvedilol for Cirrhotic portal hypertension | Hepatic cirrhosis

Inclusion criteria

• {"criterion_text":"- Patient ≥ 18 years with suspected cirrhotic PH (all causes combined) 1 : according to Baveno VII criteria: Liver elasticity ≥ 25 kPa or Liver elasticity between 20 and 25 kPa with Platelets < 150 G/L or Liver elasticity between 15 and 20 kPa with Platelets < 110 G/L or Liver elasticity > 20 kPa and/or Platelets < 150 G/L for patients with cirrhosis developed from NASH or Gastroesophageal varices at high risk of rupture: Size > 5 mm (stage 2 or 3) or Size ≤ 5 mm and red signs or Size ≤ 5 mm and CHILD-PUGH C. 2. and/or the presence of a radiological sign of PHT: Porto-systemic shunts: rectal varices, splenorenal shunts, re-canalization of the umbilical vein. 3. and/or splenic elasticity > 50 kPa."}
• {"criterion_text":"- Patient naïve to any treatment with non-cardioselective beta-blockers."}
• {"criterion_text":"- Affiliation to a Social Security scheme."}

Exclusion criteria

• {"criterion_text":"- Absolute contraindications to beta-blockers: bradycardia ≤ 50 bpm, systolic arterial hypotension (systolic arterial pressure ≤ 90 mmHg), grade II or III atrioventricular block, decompensated heart failure, pulmonary arterial hypertension, severe peripheral arterial disease, Raynaud's syndrome, asthma."}
• {"criterion_text":"- Patients on antiplatelet drugs (except acetylsalicylic acid) or on anticoagulants for emboligenic AC/AF."}
• {"criterion_text":"- Severe chronic renal failure stage 4 or end-stage renal failure stage 5 (clearance < 30 mL/min)."}
• {"criterion_text":"- Pregnant or breastfeeding women, or those planning to become pregnant. A pregnancy test will be performed for women of childbearing age."}
• {"criterion_text":"- Patients protected by law (under guardianship, curatorship or legal protection) or deprived of their liberties."}
• {"criterion_text":"- Presence of severe acute alcoholic hepatitis (Madrey score ≥ 32)."}
• {"criterion_text":"- Current hepatic encephalopathy ≥ Grade 2."}
• {"criterion_text":"- Hepatorenal syndrome in progress."}
• {"criterion_text":"- Clinical ascites of great abundance: only if bothersome for the feasibility of the EHH."}
• {"criterion_text":"- History of ruptured esophageal varices."}
• {"criterion_text":"- Hepatocellular carcinoma active or in remission for less than six months."}
• {"criterion_text":"- Active or resolved portal vein thrombosis for less than six months."}
• {"criterion_text":"- Digestive surgical history not allowing the feasibility of measuring the portosystemic gradient by echo-endoscopy (gastrectomy, bypass, etc.)."}

Primary endpoints

• {"endpoint_text":"- Hemodynamic response (binary efficacy criterion) at one month, defined by a decrease of at least 10% in the echo-endoscopic portosystemic gradient compared to the baseline value measured at inclusion.","definition_or_measurement_approach":"Defined as a decrease of at least 10% in the echo-endoscopic portosystemic gradient compared to baseline measured at inclusion; assessed at one month."}

Secondary endpoints

• {"endpoint_text":"- Top ten side effects of beta-blockers reported in the literature, and percentage of patients who discontinue treatment due to side effects.","definition_or_measurement_approach":"Collection and reporting of the top ten beta-blocker side effects from literature; calculation of percentage of patients who discontinue treatment due to side effects."}
• {"endpoint_text":"- Digestive bleeding linked to rupture of esophageal or gastric varices within three months of starting treatment.","definition_or_measurement_approach":"Occurrence of digestive bleeding due to rupture of esophageal or gastric varices within three months of treatment initiation."}
• {"endpoint_text":"- Biological and elastometric parameters measured before and after taking Carvedilol for three months.","definition_or_measurement_approach":"Measurement of specified biological and elastometric parameters at baseline and after three months of Carvedilol treatment; comparison of values before and after treatment."}

France

Earliest CTIS Part Ii Submission Date

14-01-2025

Latest Decision Or Authorization Date

25-08-2025

Processing Time Days

223

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

University Hospital Of Clermont-Ferrand

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France