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Effect of Carvedilol on the portosystemic gradient as measured by endoscopic ultrasound
EU CTIS ID: 2024-518302-41-00
What this study is testing
To evaluate the efficacy at one month of Carvedilol 12.5 mg per day, in primary prophylaxis of digestive hemorrhage linked to PH of cirrhotic origin, by measuring the portosystemic gradient by echo-endoscopy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- Patient naïve to any treatment with non-cardioselective beta-blockers.
- Affiliation to a Social Security scheme.
You likely can't join if
- 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.
- Patients on antiplatelet drugs (except acetylsalicylic acid) or on anticoagulants for emboligenic AC/AF.
- Severe chronic renal failure stage 4 or end-stage renal failure stage 5 (clearance < 30 mL/min).
- Pregnant or breastfeeding women, or those planning to become pregnant. A pregnancy test will be performed for women of childbearing age.
- Patients protected by law (under guardianship, curatorship or legal protection) or deprived of their liberties.
- Presence of severe acute alcoholic hepatitis (Madrey score ≥ 32).
See the full eligibility criteria
- 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.
- Patient naïve to any treatment with non-cardioselective beta-blockers.
- Affiliation to a Social Security scheme.
- 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.
- Patients on antiplatelet drugs (except acetylsalicylic acid) or on anticoagulants for emboligenic AC/AF.
- Severe chronic renal failure stage 4 or end-stage renal failure stage 5 (clearance < 30 mL/min).
- Pregnant or breastfeeding women, or those planning to become pregnant. A pregnancy test will be performed for women of childbearing age.
- Patients protected by law (under guardianship, curatorship or legal protection) or deprived of their liberties.
- Presence of severe acute alcoholic hepatitis (Madrey score ≥ 32).
- Current hepatic encephalopathy ≥ Grade 2.
- Hepatorenal syndrome in progress.
- Clinical ascites of great abundance: only if bothersome for the feasibility of the EHH.
- History of ruptured esophageal varices.
- Hepatocellular carcinoma active or in remission for less than six months.
- Active or resolved portal vein thrombosis for less than six months.
- Digestive surgical history not allowing the feasibility of measuring the portosystemic gradient by echo-endoscopy (gastrectomy, bypass, etc.).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.