Effect of Long-term Carvedilol to Prevent Decompensation or Death in Patients With Asymptomatic C… (NCT06263816) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Effect of Long-term Carvedilol to Prevent Decompensation or Death in Patients With Asymptomatic Child-Pugh A5 to B8 Cirrhosis and Clinically Significant Portal Hypertension: a Multicenter Double-blind Randomized Control Trial
France290 participantsStarted 2025-06-17
Plain-language summary
Decompensation of cirrhosis is a turning point in cirrhosis course, as associated with a marked decrease in life expectancy. Thus, prevention of decompensation is crucial.
The usefulness of carvedilol to prevent decompensation of cirrhosis in patients with TE-LSM ≥ 25 kPa as a surrogate marker for clinically significant portal hypertension, has never been evaluated in a clinical trial.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female≥ 18 years of age
* Cirrhosis related to hepatitis C or hepatitis B virus without viral replication for at least 2 years.
Or Cirrhosis related to alcohol consumption (active or abstinent) Or Cirrhosis related to metabolic syndrome or cryptogenic with BMI \< 30 kg/m2
* 2 TE-LSM (Fibroscan®) performed in fasting conditions, using either the M or the XL probe \>=25 kPa, within 12 months before inclusion
* Absence of medium or large varices or small varices with red signs at endoscopy within 3 months before inclusion
* Child-Pugh A5 to B8
* Affiliation to a French social security system.
* Written informed consent obtained from the participant or participant's legal representative
* For child-bearing aged women, contraception using oral contraceptive, or intrauterine device or mechanical contraception
Exclusion Criteria:
* History of overt ascites or encephalopathy \<12 months before inclusion
* Treatment with either diuretics or lactulose or rifaximin \<3 months before inclusion
* Any history of portal hypertension related bleeding
* Baseline heart rate \<65/min or systolic blood pressure \<100 mm Hg
* Previous transjugular intrahepatic portosystemic shunt (TIPSS) or liver transplantation
* Previous history or active hepatocellular carcinoma
* Glomerular filtration rate (CKD-Epi) \< 30 mL/min
* Strict indication to selective or nonselective beta-blockers: history of acute myocardial infarction, congestive heart failure
* Strict contraindi…
What they're measuring
1
To evaluate the effect of low dose carvedilol (<=12.5 mg per day) versus placebo on the occurrence of decompensation of cirrhosis or liver-related death at 36 months