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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Carvedilol per os, day 1:3.125 mg once, day 2 to day 8: 6.25 mg/day (3.125 mg twice a day), day 9 to day 90 (end of study visit): 12.5 mg/day (6.25 mg twice a day). After the end of the study, treatment with Carvedilol will be prescribed by a cardiologist and continued at the dose of 12.5 mg/day. The follow-up of the patient will be then done according to the standard practice.
Lise Laclautre
Clermont-Ferrand, France
NOT_YET_RECRUITINGChu Estaing Medecine Digestive Et Hepatobiliaire
Clermont-Ferrand, France
RECRUITINGPercentage of participants with a reduction of at least 10% in the porto-systemic gradient
Hemodynamic response (binary efficacy criterion), defined as a reduction of at least 10% in the echo-endoscopic portosystemic gradient compared with the baseline value measured at inclusion.
Time frame: One month after starting carvedilol.
Side-effects of beta blockers
Side effects of beta-blockers among the top ten reported in the literature, and percentage of patients discontinuing treatment due to side effects.
Time frame: From enrollment to D90.
Number of participants with digestive hemorrhage
Digestive hemorrhage due to rupture of esophageal or gastric varices.
Time frame: Within three months of starting Carvedilol.
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