Can a common heart drug prevent bleeding in cirrhosis?
NCT ID NCT06861075
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether carvedilol, a beta-blocker, can reduce high blood pressure in the liver's portal vein in people with cirrhosis. High pressure can lead to dangerous bleeding. Researchers will use an endoscopic ultrasound to measure pressure before and after one month of treatment. The trial enrolls 30 adults with cirrhosis and suspected portal hypertension.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Carvedilol (a beta-blocker drug)
- What this could lead to
- If it works, this could provide a simple way to measure and reduce bleeding risk in people with cirrhosis.
- What could go wrong
- This is a small, early-phase study with only 30 people. The drug may not lower pressure enough, and side effects like dizziness or fatigue are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients ≥ 18 years * Suspected portal hypertension associated with cirrhosis (of any aetiology) as defined by: 1. Baveno VII criteria : Liver stiffness ≥ 25 kPa Or Liver stiffness between 20 and 25 kPa and platelets \< 150 G/L Or Liver stiffness between 15 and 20 kPa and platelets \< 110 G/L Or Liver stiffness \> 20 kPa and/or platelets \< 150 G/L in patients with cirrhosis due to NASH Or Oesophageal varices with high risk of bleeding : Size \> 5 mm (stage 2 or 3) Or Size ≤ 5 mm and red spots Or Size ≤ 5 mm and Child-Pugh score C 2. and/or the presence of a radiological sign of portal hypertension : Portosystemic shunts: rectal varices, splenorenal shunts, repermeabilization of the umbilical vein. 3. and/or splenic elasticity \> 50 kPa. * Patients naive to treatment with cardioselective beta blockers * Affiliated to french health insurance system Exclusion Criteria: * Absolute contraindications to beta blockers : * hypersensitivity to the active substance (carvedilol) or to any of the excipients listed in section 6.1 of the summary of product characteristics * patients with severe decompensated heart failure, with signs of fluid overload (oedema, ascites, pulmonary stasis rales), and/or requiring treatment with a positive inotrope or venous vasodilator * second and third-degree atrioventricular blocks (unless presence of a permanent pacemaker) * severe bradycardia (≤ 50 bpm) * cardiac sinus disease (including sino-auricular block) * severe hypotension (systolic pressure \< 85 mm Hg) * cardiogenic shock * severe asthma, severe chronic obstructive pulmonary disease, history of severe bronchospasm * history of anaphylactic reaction * Raynaud's phenomenon * peripheral circulatory disorder: severe obliterative arterial disease of the lower limbs * association with cimetidine * association with class I antiarrhythmics except lidocaine * pulmonary arterial hypertension * Presence of severe acute alcoholic hepatitis (Madrey score ≥ 32). * Current hepatic encephalopathy ≥ Grade 2. * Ongoing hepato-renal syndrome. * Profuse clinical ascites (only if it interferes with the feasibility of echo-endoscopy). * History of oesophageal varices rupture. * Hepatocellular carcinoma active or in remission for less than six months. * Active or resolved portal vein thrombosis for less than six months. * History of digestive surgery that does not allow the porto-systemic gradient to be measured using echo-endoscopy (gastrectomy, by-pass, etc.). * Patients taking antiaggregants (except acetylsalicylic acid) or anticoagulants for embologenic CA/FA. * Severe stage 4 chronic renal insufficiency or stage 5 end-stage renal insufficiency (clearance \< 30 mL/min). * Pregnant or breast-feeding women, or those planning to become pregnant\*. \*A pregnancy test will be carried out for women of childbearing potential, and the investigator will ensure that effective contraception is in place while Carvedilol is being taken and for 5 half-lives after stopping it. * Patients protected by law (under guardianship, curatorship or safeguard of justice) or deprived of their freedom. * Patients currently taking part in another clinical research protocol. * Patients who do not understand French language.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chu Estaing Medecine Digestive Et Hepatobiliaire
RECRUITINGClermont-Ferrand, 63003, France
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Lise Laclautre
NOT_YET_RECRUITINGClermont-Ferrand, 63000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a wearable zapper quiet cirrhosis pain without drugs?
- A needle through the gut could replace the standard liver pressure test
- Can two experimental drugs be used safely in people with cirrhosis?
- Can bedside ultrasound guide fluid treatment for cirrhosis patients?