Study on the Effect of Carvedilol for Patients with Cirrhotic Portal Hypertension

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What is this study about?

This clinical trial is focused on studying the effects of the medication Carvedilol on a condition known as cirrhotic portal hypertension. Cirrhotic portal hypertension is a complication that arises from liver cirrhosis, where increased blood pressure in the portal vein can lead to serious issues like digestive bleeding. The medication being tested, Carvedilol, is a type of drug known as a beta-blocker, which is commonly used to manage blood pressure and heart-related conditions.

The purpose of this study is to evaluate how effective Carvedilol is in preventing digestive bleeding in patients with cirrhotic portal hypertension. Participants in the study will take Carvedilol at a dose of 12.5 mg per day. The study will last for about three months, during which the effects of the medication will be monitored. The main focus will be on measuring changes in the portosystemic gradient, which is a way to assess blood pressure changes in the portal vein, using a method called endoscopic ultrasound.

Throughout the study, researchers will also observe any side effects that participants may experience from taking Carvedilol. The study aims to determine if there is a significant reduction in the risk of digestive bleeding and to monitor any changes in biological and liver-related parameters. This information will help in understanding the potential benefits and risks of using Carvedilol for managing cirrhotic portal hypertension.

1 joining the study

Participation begins after meeting specific criteria, including being 18 years or older with suspected cirrhotic portal hypertension. This condition involves increased pressure in the veins that carry blood from the digestive organs to the liver.

Eligibility requires no prior treatment with non-cardioselective beta-blockers and affiliation to a social security scheme.

2 initial assessment

An initial assessment is conducted to measure the portosystemic gradient using endoscopic ultrasound. This gradient reflects the pressure difference between the portal vein and the systemic circulation.

Baseline measurements of liver elasticity and platelet count are taken to confirm the condition.

3 medication administration

The medication Carvedilol is administered orally in the form of a film-coated tablet. The dosage is 12.5 mg per day.

The treatment aims to prevent digestive hemorrhage by reducing the portosystemic gradient.

4 one-month evaluation

After one month, the primary endpoint is evaluated. This involves checking for a hemodynamic response, defined as a decrease of at least 10% in the portosystemic gradient compared to the initial measurement.

The effectiveness of the treatment is assessed based on this criterion.

5 monitoring side effects

Throughout the trial, monitoring for side effects of beta-blockers is conducted. This includes tracking the top ten side effects reported in the literature.

The percentage of participants who discontinue treatment due to side effects is recorded.

6 three-month follow-up

A follow-up is conducted three months after starting the treatment to check for any digestive bleeding linked to the rupture of esophageal or gastric varices.

Biological and elastometric parameters are measured again to assess changes after taking Carvedilol.

Who Can Join the Study?

Patient must be 18 years or older.
Patient must have suspected cirrhotic portal hypertension. This is a condition where there is increased blood pressure in the portal vein, which carries blood from the digestive organs to the liver, due to liver scarring (cirrhosis).
Patient must meet the Baveno VII criteria for cirrhotic portal hypertension, which includes:
- Liver elasticity of 25 kPa or more. Liver elasticity is a measure of how stiff the liver is, often due to scarring.
- Liver elasticity between 20 and 25 kPa with platelets less than 150 G/L. Platelets are cells in the blood that help with clotting.
- Liver elasticity between 15 and 20 kPa with platelets less than 110 G/L.
- Gastroesophageal varices at high risk of rupture. These are swollen veins in the esophagus or stomach that can bleed. High risk includes:
  - Size greater than 5 mm (stage 2 or 3).
  - Size 5 mm or less with red signs, which are marks indicating a higher risk of bleeding.
  - Size 5 mm or less and classified as CHILD-PUGH C, which is a score used to assess the severity of liver disease.
Patient must not have had any treatment with non-cardioselective beta-blockers. These are medications that affect the heart and blood vessels.
Patient must be affiliated with a Social Security scheme.
Both male and female patients are eligible.
Patients from a vulnerable population are not selected for this study.

Who Cannot Join the Study?

Patients who are not between the ages of 18 and 65 cannot participate.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, are not eligible.
Patients who have medical conditions other than cirrhotic portal hypertension are excluded. Cirrhotic portal hypertension is a condition where there is high blood pressure in the veins that carry blood to the liver due to liver damage.
Patients who are not able to take the study medication, Carvedilol, which is used to lower blood pressure, cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients who are currently participating in another clinical trial are excluded.
Patients who have a history of allergic reactions to similar medications are not eligible.
Patients with severe heart conditions that are not stable are excluded.
Patients with severe kidney problems are not eligible to participate.
Patients who have a history of alcohol or drug abuse are excluded from the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.01.2025

Trial locations

Investigated drugs:

Carvedilol

Carvedilol is a medication used in this trial to help prevent digestive bleeding in patients with liver cirrhosis. It works by reducing the pressure in the blood vessels of the liver, which can help lower the risk of bleeding. The study aims to see how effective this medication is after one month of use.

Investigated diseases:

Hepatic cirrhosis

Cirrhotic Portal Hypertension – This condition occurs when there is increased blood pressure in the portal vein system, which carries blood from the digestive organs to the liver. It is often a result of cirrhosis, where scar tissue in the liver obstructs blood flow. As the pressure builds, it can lead to the development of enlarged veins, known as varices, in the esophagus and stomach. These varices are prone to rupture, which can cause significant bleeding. Over time, the increased pressure can also lead to fluid accumulation in the abdomen, known as ascites. The progression of this condition can lead to various complications related to liver function and blood circulation.

Trial ID:

2024-518302-41-00

Protocol code:

AOI 2023 POINCLOUX

NCT ID:

NCT06861075

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effect of Carvedilol for Patients with Cirrhotic Portal Hypertension

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