An interventional study of conventional therapy and propranolol in Cirrhosis, sponsored by General Hospital of Shenyang Military Region. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by General Hospital of Shenyang Military Region · Not applicable, Interventional, and Treatment
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.
This is a non-inferiority, randomized controlled trial. A total of 466 decompensated cirrhotic patients with a MELD score of >9 will be enrolled. Participants will be stratified based on the presence or absence of acute decompensation at enrollment, and then randomly assigned at a 1:1 ratio to conventional treatment combined with or without propranolol groups. All patients will receive standard medical therapy in both groups, and then regularly followed. The primary outcome is further decompensation. The secondary outcomes include recompensation and death.
1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.
This study's planned enrollment of 466 is above the median of 63 across 840 interventional studies indexed under Fibrosis.
Browse Fibrosis studies →General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients are provided with conventional supportive treatment only, but without nonselective beta blockers.
Other: conventional therapy
Patients are administered with propranolol in addition to conventional treatment.
Drug: propranolol
Conventional 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 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.
Also known as: Inderal
The time from randomization to the occurrence of further decompensation
Further decompensation is defined as any of the following conditions: 1. the occurrence of a second portal hypertension driven decompensation event (ascites, variceal bleeding or HE) and/or non-obstructive jaundice; 2. the occurrence of recurrent variceal bleeding, refractory ascites, recurrent HE, SBP, and/or HRS-AKI; 3. the occurrence of ascites, HE, or jaundice in patients with bleeding alone after recovery from bleeding, according to the Baveno VII consensus.
Time frame: Time to first further decompensation event, assessed from randomization up to the end of the study (maximum of approximately 96 weeks)
The time from randomization to the occurrence of recompensation
Recompensation is defined as all of the following criteria are met: 1. removal/suppression/cure of the primary cause of cirrhosis (e.g., removal of hepatitis C virus, sustained suppression of hepatitis B virus, or sustained alcohol abstinence in alcoholic cirrhosis); 2. resolution of ascites in the setting of discontinuation of diuretics, absence of HE in the setting of discontinuation of lactulose/rifaximin, and absence of recurrent variceal bleeding within at least 12 months; 3. stable improvement of liver function (e.g., albumin, international normalized ratio, bilirubin)
Time frame: Time to first recompensation event, assessed from randomization up to the end of the study (maximum of approximately 96 weeks)
The time from randomization to the occurrence of death
All-cause mortality during the study period
Time frame: assessed from randomization up to the end of the study (maximum of approximately 96 weeks)
The composite endpoint of further decompensation and death
Time frame: assessed from randomization up to the end of the study (maximum of approximately 96 weeks)
The hierarchical composite endpoint of death and further decompensation
Time frame: assessed from randomization up to the end of the study (maximum of approximately 96 weeks)
The time from randomization to the occurrence of individual decompensation events
Individual decompensation event is defined as the time from randomization to the first occurrence of each event during the follow-up period. Individual decompensation events include: 1. first variceal bleeding (in patients without prior bleeding history); 2. variceal rebleeding (in patients with prior bleeding history); 3. ascites; 4. HE; 5. jaundice; 6. hepatorenal syndrome (HRS); 7. SBP
Time frame: assessed from randomization up to the end of the study (maximum of approximately 96 weeks
Plan to share: No
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General Hospital of Shenyang Military Region