Carvedilol effect on portal pressure measured by endoscopic ultrasound

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label interventional study gives adults with cirrhosis carvedilol, starting at a low dose and titrated to 12.5 mg/day, and measures the portal pressure gradient by endoscopic ultrasound (EUS-PPG) at baseline and after about one month of treatment. Participants undergo an initial oesogastroduodenal endoscopy with EUS-PPG, scheduled clinic visits for safety monitoring and dose titration, and a follow-up endoscopy with repeat EUS-PPG at 30–45 days. Eligibility is based on suspected portal hypertension by Baveno VII criteria, radiologic signs, or high splenic stiffness, and patients must be naive to cardioselective beta blockers. The trial is conducted at CHU Clermont-Ferrand with routine clinical monitoring (vitals, ECG if indicated, adverse event reporting) throughout the 90-day protocol period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chu Estaing Medecine Digestive Et Hepatobiliaire
  Clermont-Ferrand, France Recruiting
• Lise Laclautre
  Clermont-Ferrand, France Not yet recruiting

Study contacts

• Principal investigator: Armando Abergel — University Hospital, Clermont-Ferrand
• Study coordinator: Lise Laclautre
• Email: promo_internet_drci@chu-clermontferrand.fr
• Phone: +33473754963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.