Impact of Propranolol on the Prognosis of Patients With Decompensated Cirrhosis and MELD Score > 9
- Sponsor
- General Hospital of Shenyang Military Region
- Study ID
- NCT07652203
- Status
- Not Yet Recruiting
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Conditions
- Cirrhosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- conventional therapy — OTHERConventional treatment of decompensated cirrhosis mainly includes anti-hepatic fibrosis drugs, albumin infusion, diuretics, peritoneal drainage, esophageal variceal ligation, endoscopic tissue adhesive injection, blood purification, and liver transplantation.
- propranolol — DRUGPropranolol will be started with 10-20 mg/day for the propranolol group, which will be gradually increased to the maximum tolerance dosage or achieve a heart rate of 55-60 beats per minute and a systolic blood pressure of 90mmHg.
Study Details
Non selective beta blockers (NSBBs), such as propranolol and nadolol, are mainstay therapies for portal hypertension in cirrhosis, but their efficacy and safety vary depending on the stage of the disease. Emerging evidence suggests that NSBBs may worsen the prognosis of advanced cirrhosis, especially in patients with a model for end-stage liver disease (MELD) score of \>9. The purpose of this randomized controlled trial is to evaluate the effects of the use of propranolol as recommended by the guideline on the prognosis in cirrhotic patients with a MELD score of \>9.
Key Dates
- First listed
- Jun 16, 2026
- Start date
- Jun 30, 2026
- Status verified
- Jun 2026
- Primary completion
- Jul 31, 2027
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 466 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Conventional treatment without propranololPatients are provided with conventional supportive treatment only, but without nonselective beta blockers.
- Active Comparator: Conventional treatment combined with propranololPatients are administered with propranolol in addition to conventional treatment.
Primary Outcome Measure
The time from randomization to the occurrence of further decompensation [ Time Frame: Time to first further decompensation event, assessed from randomization up to the end of the study (maximum of approximately 96 weeks) ]
Central Contacts
- Xingshun Qi, MD18909881019
- Li He18473457053
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