Clinical trial NCT05651789: Carvedilol vs. Propranolol in Second Prophylaxis of Variceal Bleeding
Official title: Randomized Controlled Trial on the Effectiveness and Safety of Carvedilol vs. Propranolol Combined With Endoscopic Treatment in Second Prophylaxis of Variceal Bleeding in Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Portal Hypertension
Varice Bleed
Cirrhosis, Liver
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Chengdu Shangjin Nanfu Hospital
name: West China Tianfu Hospital
First posted: 2022-12-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled trial was conducted to evaluate the efficacy and safety of carvedilol versus propranolol, combined with routine endoscopic treatment, in the secondary prophylaxis of variceal bleeding in patients with cirrhosis.

Detailed description: Non-selective beta blockers combined with endoscopic variceal band ligation (EVL) is the most effective methods for the prevention of variceal bleeding. Carvedilol has emerged as the preferred NSBB for treating portal hypertension in compensated cirrhosis due to strong evidence demonstrating that it has a more pronounced effect than propranolol to reduce the hepatic vein pressure gradient (HVPG), together with good patient acceptability and safety profile. However, No data from prospectively designed trials are available on the efficacy of carvedilol in the secondary prophylaxis of variceal bleeding. The aim of this randomized controlled trial was to evaluate the effectiveness and safety of carvedilol compared to propranolol as secondary prophylaxis of variceal bleeding in patients with cirrhosis. All cirrhotic patients with at least one episode of variceal bleeding were included and randomized to the carvedilol or propranolol groups. EVL protocol was routinely performed in both groups. Variceal rebleeding, further decompensation, liver-related death, and overall survival was the outcomes of this trial.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 80 years old;
* With liver cirrhosis diagnosed by previous biopsy or by clinical criteria, and analytical image;
* At least 5 days after index variceal bleeding;
* Informed consent.

Exclusion Criteria:

* Refusal to participate in the study;
* Portal hypertension resulting from other causes than liver cirrhosis;
* More than 42 days after index variceal bleeding;
* Bleeding from cardiofundal gastric varices;
* Portal venous thrombosis \>50% of the portal vein trunk;
* Contraindications to beta-blockers (asthma, chronic obstructive pulmonary disease, atrioventricular block, heart failure, bradycardia with HR ≤40 bpm, arteria hypotension with systolic blood pressure \<90 mm Hg, peripheral arterial disease, uncontrolled diabetes);
* Prior NSBB+EVL combined treatment, TIPS implantation or surgical shunt as secondary prophylaxis of variceal bledding;
* Chronic kidney disease;
* Pregnancy or lactation;
* Neoplastic disease.

Primary outcomes:
measure: Variceal rebleeding rate
timeFrame: 1 year
Secondary outcomes:
measure: Further decompensation rate
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
measure: Transplant-free survival rate
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Xuefeng Luo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: