CirrhosisCARPEUSNCT06861075
CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound
A study testing Carvedilol in people with Cirrhosis and Portal Hypertension Related to Cirrhosis, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
The purpose of this study is to assess the efficacy after one month of treatment with Carvedilol (12.5 mg daily) in primary prophylaxis of digestive haemorrhage due to portal hypertension in cirrhosis, by endoscopic ultrasound-guided portal pressure gradient measurement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Portal Hypertension Related to Cirrhosis
- What is being tested?
- Carvedilol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Apr 2025to 1 Apr 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 ≥ 18 years
- Suspected portal hypertension associated with cirrhosis (of any aetiology) as defined by:
- 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
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- and/or the presence of a radiological sign of portal hypertension : Portosystemic shunts: rectal varices, splenorenal shunts, repermeabilization of the umbilical vein.
- and/or splenic elasticity > 50 kPa.
- Patients naive to treatment with cardioselective beta blockers
- Affiliated to french health insurance system
Who cannot join
- 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)
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Lise Laclautre
Clermont-Ferrand, 63000
Armando Abergel
- Recruiting
Chu Estaing Medecine Digestive Et Hepatobiliaire
Clermont-Ferrand, 63003
Armando ABERGEL, +33473750523, aabergel@chu-clermontferrand.fr
About this study
The purpose of this study is to assess the efficacy after one month of treatment with Carvedilol (12.5 mg daily) in primary prophylaxis of digestive haemorrhage due to portal hypertension in cirrhosis, by endoscopic ultrasound-guided portal pressure gradient measurement.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for entry study.
- Inclusion visit (day 1) includes an oesogastroduodenal fibroscopy (OGDF) followed by an endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement, an electrocardiogram, a clinical examination, and a first intake of study treatment : Carvedilol 3.125 mg.
Carvedilol, day 2 to day 8: 6.25 mg/day (3.125 mg twice a day). - Visit 2 (day 6 +/- 2 days): clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram if indicated, assessment of compliance with study treatment.
Carvedilol, day 9 to day 90 (end of study visit): 12.5 mg/day (6.25 mg twice a day).
- Visit 3 (day 13 +/- 2 days): clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram if indicated, assessment of compliance with study treatment.
Carvedilol will be continued at the dose of 12.5 mg/day, on a long-term basis. - Visit 4 (day 30-45): OGDF followed by an EUS-PPG measurement, clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram if indicated, assessment of compliance with study treatment.
Carvedilol will be continued at the dose of 12.5 mg/day.
- Visit 5 (day 90 +/- 7 jours), end of study visit: clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram, assessment of compliance with study treatment.
Treatment with Carvedilol will be prescribed by a cardiologist and continued at the dose of 12.5 mg/day.
Follow-up of the patient according to standard practice. NB: an adaptation of the dose of Carvedilol may be considered according to tolerability, throughout the study.
- Being tested
- Carvedilol
- Keywords
- Carvedilol., Portal hypertension in cirrhosis., EUS-PPG measurement.
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Also called CARVEDILOL ARROW ® 6,25 mg
Carvedilol per os, day 1:3.125 mg once, day 2 to day 8: 6.25 mg/day (3.125 mg twice a day), day 9 to day 90 (end of study visit): 12.5 mg/day (6.25 mg twice a day).
After the end of the study, treatment with Carvedilol will be prescribed by a cardiologist and continued at the dose of 12.5 mg/day.
The follow-up of the patient will be then done according to the standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | All patients will receive Carvedilol per os (dose escalation up to 12.5 mg per day). Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with a reduction of at least 10% in the porto-systemic gradient
Hemodynamic response (binary efficacy criterion), defined as a reduction of at least 10% in the echo-endoscopic portosystemic gradient compared with the baseline value measured at inclusion.
Measured: One month after starting carvedilol.
Secondary outcomes (2)
Side-effects of beta blockers
Side effects of beta-blockers among the top ten reported in the literature, and percentage of patients discontinuing treatment due to side effects.
Measured: From enrollment to D90.
Number of participants with digestive hemorrhage
Digestive hemorrhage due to rupture of esophageal or gastric varices.
Measured: Within three months of starting Carvedilol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start16 Apr 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armando Abergel, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861075
- Sponsor's protocol ID
- AOI 2023 POINCLOUX
- Other IDs
- 2024-518302-41-00
- Acronym
- CARPEUS
- Status last verified
- Sep 2025
- First submitted
- 19 Feb 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound
- ClinicalTrials.gov ID
- NCT06861075
- Acronym / sponsor ID
- CARPEUS / AOI 2023 POINCLOUX
- Keywords
- Carvedilol., Portal hypertension in cirrhosis., EUS-PPG measurement.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 6 Mar 2025 (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.
The purpose of this study is to assess the efficacy after one month of treatment with Carvedilol (12.5 mg daily) in primary prophylaxis of digestive haemorrhage due to portal hypertension in cirrhosis, by endoscopic ultrasound-guided portal pressure gradient measurement.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for entry study.
- Inclusion visit (day 1) includes an oesogastroduodenal fibroscopy (OGDF) followed by an endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement, an electrocardiogram, a clinical examination, and a first intake of study treatment : Carvedilol 3.125 mg.
Carvedilol, day 2 to day 8: 6.25 mg/day (3.125 mg twice a day). - Visit 2 (day 6 +/- 2 days): clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram if indicated, assessment of compliance with study treatment.
Carvedilol, day 9 to day 90 (end of study visit): 12.5 mg/day (6.25 mg twice a day).
- Visit 3 (day 13 +/- 2 days): clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram if indicated, assessment of compliance with study treatment.
Carvedilol will be continued at the dose of 12.5 mg/day, on a long-term basis. - Visit 4 (day 30-45): OGDF followed by an EUS-PPG measurement, clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram if indicated, assessment of compliance with study treatment.
Carvedilol will be continued at the dose of 12.5 mg/day.
- Visit 5 (day 90 +/- 7 jours), end of study visit: clinical examination, record of potential adverse events, vital signs (arterial pressure, pulse rate), electrocardiogram, assessment of compliance with study treatment.
Treatment with Carvedilol will be prescribed by a cardiologist and continued at the dose of 12.5 mg/day.
Follow-up of the patient according to standard practice. NB: an adaptation of the dose of Carvedilol may be considered according to tolerability, throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: CarvedilolAll patients will receive Carvedilol per os (dose escalation up to 12.5 mg per day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients ≥ 18 years
- Suspected portal hypertension associated with cirrhosis (of any aetiology) as defined by:
- 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
- Size > 5 mm (stage 2 or 3) Or Size ≤ 5 mm and red spots Or Size ≤ 5 mm and Child-Pugh score C
- Patients naive to treatment with cardioselective beta blockers
Key exclusion criteria (30 listed)
- Absolute contraindications to beta blockers :
- 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).
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 |
|---|---|---|
| CarvedilolAlso: CARVEDILOL ARROW ® 6,25 mgCarvedilol per os, day 1:3.125 mg once, day 2 to day 8: 6.25 mg/day (3.125 mg twice a day), day 9 to day 90 (end of study visit): 12.5 mg/day (6.25 mg twice a day). After the end of the study, treatment with Carvedilol will be prescribed by a cardiologist and continued at the dose of 12.5 mg/day. The follow-up of the patient will be then done according to the standard practice. | Drug | Single arm |
Primary outcome
Percentage of participants with a reduction of at least 10% in the porto-systemic gradient
Time frame: One month after starting carvedilol.
Hemodynamic response (binary efficacy criterion), defined as a reduction of at least 10% in the echo-endoscopic portosystemic gradient compared with the baseline value measured at inclusion.
2 secondary outcomes
Side-effects of beta blockers
Time frame: From enrollment to D90.
Number of participants with digestive hemorrhage
Time frame: Within three months of starting Carvedilol.
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 22 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Armando Abergel principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carvedilol in people with Cirrhosis and Portal Hypertension Related to Cirrhosis, run by University Hospital, Clermont-Ferrand at 2 sites in France.
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 10 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Lise Laclautre (+33473754963, promo_internet_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with a reduction of at least 10% in the porto-systemic gradient (time frame: One month after starting carvedilol.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2025.