CirrhosisNCT07652203

Impact of Propranolol on the Prognosis of Patients With Decompensated Cirrhosis and MELD Score > 9

A study testing conventional therapy and propranolol in people with Cirrhosis, run by General Hospital of Shenyang Military Region at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cirrhosis
What is being tested?: conventional therapy and propranolol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 466 participants
Where: 1 siteChina
Study dates: Sep 2026to Jul 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients' age ≥18 years;
patients with a definitive diagnosis of liver cirrhosis;
patients with a MELD score of >9;
patients with a history of decompensation or those who are experiencing their first decompensation, such as ascites, variceal bleeding, or hepatic encephalopathy (HE);
patients' informed consents.

Who cannot join

patients without a definite indication for NSBBs;
patients with an absolute contraindication of NSBBs (severe bronchospasm, asthma, severe psychosis, high-degree atrioventricular block, etc.);
patients with hypersensitivity to NSBBs;
patients who had been treated with NSBBs before 2 weeks of enrollment;
patients with occlusive portal vein thrombosis;
patients who had undergone liver transplantation;

Show all 10Show fewer

patients who had undergone transjugular intrahepatic portosystemic shunt (TIPS);
patients with a definitive diagnosis of hepatocellular carcinoma;
patients with an estimated life time of <12 months due to the presence of any comorbidities;
patients who are currently pregnant or breast-feeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xingshun Qi, MD contact

Li He contact

China1 site

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning
Xingshun Qi, MD, 18909881019, xingshunqi@126.com
Li He, 18473457053, lihee228@163.com

Other trials in China

About this study

Official title: Impact of Propranolol on the Prognosis of Patients With Decompensated Cirrhosis and MELD Score > 9: a Non-inferiority Randomized Controlled Trial

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.

Read the detailed description

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.

Conditions: Cirrhosis
Being tested: conventional therapy, propranolol
Keywords: cirrhosis, propranolol, decompensation, recompensation, survival, MELD
Medical subject headings: Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

conventional therapyOther
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.
propranololDrug
Also called Inderal
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.

Study groups in NCT07652203
Study group	Role	What they receive
Conventional treatment without propranolol	Experimental	Patients are provided with conventional supportive treatment only, but without nonselective beta blockers. Receives: Other: conventional therapy
Conventional treatment combined with propranolol	Active comparator	Patients are administered with propranolol in addition to conventional treatment. Receives: Drug: propranolol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Time to first further decompensation event, assessed from randomization up to the end of the study (maximum of approximately 96 weeks)

Secondary outcomes (5)

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)
Measured: 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
Measured: assessed from randomization up to the end of the study (maximum of approximately 96 weeks)
The composite endpoint of further decompensation and death
Measured: assessed from randomization up to the end of the study (maximum of approximately 96 weeks)
The hierarchical composite endpoint of death and further decompensation
Measured: 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
Measured: assessed from randomization up to the end of the study (maximum of approximately 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2026Jul 2028

First posted16 Jun 2026
Study startSep 2026 (estimated)
Primary completionJul 2027 (estimated)
Study completionJul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for CirrhosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment
Masking: None (open label)
Enrolment: 466 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07652203
Sponsor's protocol ID: XHNKKY-NSBBs-2.2
Status last verified: Sep 2026
First submitted: 11 Jun 2026
Last updated: 15 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alvarado-Tapias E, Ardevol A, Garcia-Guix M, Montanes R, Pavel O, Cuyas B, Graupera I, Brujats A, Vilades D, Colomo A, Poca M, Torras X, Guarner C, Concepcion M, Aracil C, Torres F, Villanueva C. Short-term hemodynamic effects of beta-blockers influence survival of patients with decompensated cirrhosis. J Hepatol. 2020 Oct;73(4):829-841. doi: 10.1016/j.jhep.2020.03.048. Epub 2020 Apr 13.
PubMed 32298768
Serste T, Melot C, Francoz C, Durand F, Rautou PE, Valla D, Moreau R, Lebrec D. Deleterious effects of beta-blockers on survival in patients with cirrhosis and refractory ascites. Hepatology. 2010 Sep;52(3):1017-22. doi: 10.1002/hep.23775.
PubMed 20583214
Wang T, Wang X, Jia S, Zhao H, Wang L, Zhang X, Fang X, He Y, Li H, Tacke F, Qi X. Impact of non-selective beta blockers on further decompensation and death in decompensated cirrhosis: Benefit and risk stratification by MELD score. Aliment Pharmacol Ther. 2024 Nov;60(10):1409-1420. doi: 10.1111/apt.18261. Epub 2024 Sep 19.
PubMed 39300691
Cales P, Bertrais S, Boursier J, Fouchard I, Oberti F; SNIFF 16 group. Non-selective beta-blockers increase overall and liver mortality in alcoholic cirrhosis with MELD >/= 12 over 5 years of follow-up. Liver Int. 2021 Jan;41(1):168-179. doi: 10.1111/liv.14674.
PubMed 32979020
Tittanegro T, China L, Forrest E, Kallis Y, Ryder SD, Wright G, Freemantle N, O'Brien A. Use of non-selective B-blockers is safe in hospitalised decompensated cirrhosis patients and exerts a potential anti-inflammatory effect: Data from the ATTIRE trial. EClinicalMedicine. 2022 Nov 14;55:101716. doi: 10.1016/j.eclinm.2022.101716. eCollection 2023 Jan.
PubMed 36407574

Interested in taking part?

Xingshun Qi, MD

18909881019

xingshunqi@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Propranolol on the Prognosis of Patients With Decompensated Cirrhosis and MELD Score > 9: a Non-inferiority Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07652203
Acronym / sponsor ID: XHNKKY-NSBBs-2.2
Conditions: Cirrhosis
Keywords: cirrhosis, propranolol, decompensation, recompensation, survival, MELD
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 466 participants (estimated)
Lead sponsor: General Hospital of Shenyang Military RegionUniversity, hospital or other
Study start: Sep 2026 (estimated)
Primary completion: Jul 2027 (estimated)
Study completion: Jul 2028 (estimated)
First posted: 16 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Parallel Assignment

Arm	Type	Receives
Conventional treatment without propranolol	Experimental	Other: conventional therapyPatients are provided with conventional supportive treatment only, but without nonselective beta blockers.
Conventional treatment combined with propranolol	Active comparator	Drug: propranololPatients are administered with propranolol in addition to conventional treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

patients' age ≥18 years;
patients with a definitive diagnosis of liver cirrhosis;
patients with a MELD score of >9;
patients with a history of decompensation or those who are experiencing their first decompensation, such as ascites, variceal bleeding, or hepatic encephalopathy (HE);
patients' informed consents.

Key exclusion criteria (10 listed)

patients without a definite indication for NSBBs;
patients with an absolute contraindication of NSBBs (severe bronchospasm, asthma, severe psychosis, high-degree atrioventricular block, etc.);
patients with hypersensitivity to NSBBs;
patients who had been treated with NSBBs before 2 weeks of enrollment;
patients with occlusive portal vein thrombosis;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
conventional therapyConventional 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.	Other	Conventional treatment without propranolol
propranololAlso: InderalPropranolol 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.	Drug	Conventional treatment combined with propranolol

Primary outcome

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)
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.

5 secondary outcomes

The time from randomization to the occurrence of recompensation
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
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
Time frame: assessed from randomization up to the end of the study (maximum of approximately 96 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
Results publication: PubMed 32298768Alvarado-Tapias E, Ardevol A, Garcia-Guix M, Montanes R, Pavel O, Cuyas B, Graupera I, Brujats A, Vilades D, Colomo A, Poca M, Torras X, Guarner C, Concepcion M, Aracil C, Torres F, Villanueva C. Short-term hemodynamic effects of beta-blockers influence survival of patients with decompensated cirrhosis. J Hepatol. 2020 Oct;73(4):829-841. doi: 10.1016/j.jhep.2020.03.048. Epub 2020 Apr 13.
Results publication: PubMed 20583214Serste T, Melot C, Francoz C, Durand F, Rautou PE, Valla D, Moreau R, Lebrec D. Deleterious effects of beta-blockers on survival in patients with cirrhosis and refractory ascites. Hepatology. 2010 Sep;52(3):1017-22. doi: 10.1002/hep.23775.
Results publication: PubMed 39300691Wang T, Wang X, Jia S, Zhao H, Wang L, Zhang X, Fang X, He Y, Li H, Tacke F, Qi X. Impact of non-selective beta blockers on further decompensation and death in decompensated cirrhosis: Benefit and risk stratification by MELD score. Aliment Pharmacol Ther. 2024 Nov;60(10):1409-1420. doi: 10.1111/apt.18261. Epub 2024 Sep 19.
Results publication: PubMed 32979020Cales P, Bertrais S, Boursier J, Fouchard I, Oberti F; SNIFF 16 group. Non-selective beta-blockers increase overall and liver mortality in alcoholic cirrhosis with MELD >/= 12 over 5 years of follow-up. Liver Int. 2021 Jan;41(1):168-179. doi: 10.1111/liv.14674.
Results publication: PubMed 36407574Tittanegro T, China L, Forrest E, Kallis Y, Ryder SD, Wright G, Freemantle N, O'Brien A. Use of non-selective B-blockers is safe in hospitalised decompensated cirrhosis patients and exerts a potential anti-inflammatory effect: Data from the ATTIRE trial. EClinicalMedicine. 2022 Nov 14;55:101716. doi: 10.1016/j.eclinm.2022.101716. eCollection 2023 Jan.
Individual participant dataSharing planned: No

Related trials for Cirrhosis

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
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Recruiting
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Xingshun Qi, MD contact

Li He contact

Li He principal investigator

Department of Gastroenterology, General Hospital of Northern Theater Command

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing conventional therapy and propranolol in people with Cirrhosis, run by General Hospital of Shenyang Military Region at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xingshun Qi, MD (18909881019, xingshunqi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07652203, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.