Effect of Carvedilol on the portosystemic gradient as measured by endoscopic ultrasound
- Conditions
- cirrhotic portal hypertension
- Registration Number
- 2024-518302-41-00
- Lead Sponsor
- University Hospital Of Clermont-Ferrand
- Brief Summary
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.
- Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for entry study.
- Inclusion visit (day 1) includes an oesogastroduodenal fibroscopy (OGDF) followed by an endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement, an electrocardiogram, a clinical examination, and a first intake of study treatment : Carvedilol 3.125 mg.
Carvedilol, day 2 to day 8: 6.25 mg/day (3.125 mg twice a day). - Visit 2 (day 6 +/- 2 days): clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram if indicated, assessment of compliance with study treatment.
Carvedilol, day 9 to day 90 (end of study visit): 12.5 mg/day (6.25 mg twice a day).
- Visit 3 (day 13 +/- 2 days): clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram if indicated, assessment of compliance with study treatment.
Carvedilol will be continued at the dose of 12.5 mg/day, on a long-term basis. - Visit 4 (day 30-45): OGDF followed by an EUS-PPG measurement, clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram if indicated, assessment of compliance with study treatment.
Carvedilol will be continued at the dose of 12.5 mg/day.
- Visit 5 (day 90 +/- 7 jours), end of study visit: clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram, assessment of compliance with study treatment.
Treatment with Carvedilol will be prescribed by a cardiologist and continued at the dose of 12.5 mg/day.
Follow-up of the patient according to standard practice. NB: an adaptation of the dose of Carvedilol may be considered according to tolerability, throughout the study.
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Patient ≥ 18 years with suspected cirrhotic PH (all causes combined) 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 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.
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.
BMI ≥ 30 kg/m2 in case of cirrhosis developed on NASH alone.
Current hepatic encephalopathy ≥ Grade 2.
Hepatorenal syndrome in progress.
Clinical ascites of great abundance
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.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method Top ten side effects of beta-blockers reported in the literature, and percentage of patients who discontinue treatment due to side effects. Top ten side effects of beta-blockers reported in the literature, and percentage of patients who discontinue treatment due to side effects.
Digestive bleeding linked to rupture of esophageal or gastric varices within three months of starting treatment. Digestive bleeding linked to rupture of esophageal or gastric varices within three months of starting treatment.
Biological and elastometric parameters measured before and after taking Carvedilol for three months. Biological and elastometric parameters measured before and after taking Carvedilol for three months.
Related Research Topics
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Trial Locations
- Locations (1)
University Hospital Of Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
University Hospital Of Clermont-Ferrand🇫🇷Clermont-Ferrand, FranceArmando ABERGELSite contact0473750544aabergel@chu-clermontferrand.fr