CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Carvedilol
DrugCarvedilol 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Single armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage 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.Secondary outcomes
1
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 D90.2
Number of participants with digestive hemorrhage
Digestive hemorrhage due to rupture of esophageal or gastric varices.
Time frame
Within three months of starting Carvedilol.Sponsors and contacts
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Source ClinicalTrials.gov