Study on Telmisartan for Reducing Portal Hypertension in Patients with Advanced Chronic Liver Disease

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What is this study about?

This clinical trial is focused on studying the effects of the medication Telmisartan in patients with compensated advanced chronic liver disease and portal hypertension. Telmisartan is a medication commonly used to treat high blood pressure, and in this study, it is being tested to see if it can help reduce the pressure in the veins of the liver, which is a common issue in patients with these liver conditions. The study will compare the effects of Telmisartan to a placebo, which is a capsule that looks like the medication but does not contain any active ingredients.

The purpose of the study is to evaluate whether Telmisartan can lower the pressure in the liver veins after 12 weeks of treatment. Participants will be randomly assigned to receive either Telmisartan or the placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will last for 12 weeks, during which time participants will take the medication or placebo daily. The main goal is to see if there is a decrease in the pressure in the liver veins, which will be measured at the beginning and end of the study.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. The researchers will also measure changes in liver and spleen stiffness, which are indicators of liver health. This study aims to provide valuable information on whether Telmisartan can be an effective treatment for reducing liver vein pressure in patients with these liver conditions.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of compensated advanced chronic liver disease and portal hypertension.

Eligibility criteria include being between 18 and 80 years old, having a Child-Pugh stage A or B, and a model for end-stage liver disease (MELD) score of 15 or less.

2 randomization

Participants are randomly assigned to receive either telmisartan or a placebo. The placebo consists of gelatin capsules filled with maltodextrin.

The study is double-blind, meaning neither the participants nor the researchers know who receives the active medication or the placebo.

3 medication administration

Participants take Telmicard 40 mg tablets or placebo orally once daily for a duration of 12 weeks.

The goal is to evaluate the effect of telmisartan on reducing the hepatic venous pressure gradient, which is a measure of portal hypertension.

4 monitoring and follow-up

Throughout the 12-week period, participants undergo regular monitoring to assess changes in liver and spleen stiffness, as well as the hepatic venous pressure gradient.

The primary endpoint is the difference in hepatic venous pressure gradient from the start of the study to the end of the 12 weeks.

5 final assessment

At the end of the 12-week treatment period, a final assessment is conducted to evaluate the outcomes.

The study measures the response in terms of a decrease in hepatic venous pressure gradient and changes in liver and spleen stiffness.

Who Can Join the Study?

Patients must have compensated advanced chronic liver disease. This means the liver is damaged but still able to perform its functions.
Patients must be between the ages of 18 and 79 years old.
Patients must have a Child-Pugh stage of A or B. This is a scoring system used to assess the severity of liver disease.
Patients must have a model for end-stage liver disease (MELD) score of 15 points or less. This score helps to predict the risk of death from liver disease.
Patients must have clinically significant portal hypertension. This means there is increased blood pressure in the vein that carries blood to the liver, measured as a hepatic venous pressure gradient of 10 mmHg or more.
Patients must be willing to provide written informed consent, which means they agree to participate in the study after understanding all the details.

Who Cannot Join the Study?

Patients with uncontrolled high blood pressure cannot participate. This means if your blood pressure is not well-managed with medication or lifestyle changes, you may be excluded.
Individuals with severe heart problems are not eligible. This includes conditions like heart failure or recent heart attacks.
People with kidney problems that are not stable or well-managed cannot join the study.
Patients who have had a liver transplant are excluded from participating.
Those with active infections that require treatment, such as ongoing bacterial or viral infections, cannot take part.
Individuals who are pregnant or breastfeeding are not allowed to participate in the study.
Patients who are currently participating in another clinical trial are excluded to avoid interference with study results.
People with a history of alcohol or drug abuse within the past year are not eligible to join the study.
Individuals with mental health conditions that might affect their ability to follow study instructions are excluded.
Patients who have allergies to the study medication or similar drugs cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	30.11.2024

Trial locations

Investigated drugs:

Telmisartan

Telmisartan is a medication used in this trial to help lower blood pressure in the liver. It is being tested to see if it can reduce the pressure in the veins of the liver in patients who have advanced liver disease but are not yet showing severe symptoms. The goal is to see if taking this medication for 12 weeks can help decrease the pressure in the liver veins, which is important for managing liver disease.

Compensated Advanced Chronic Liver Disease – This condition refers to a stage of liver disease where the liver is significantly damaged but still able to perform its essential functions. It is characterized by the presence of fibrosis or scarring of the liver tissue, which can progress over time. Patients may not exhibit obvious symptoms, but the liver’s ability to regenerate and function is compromised. As the disease advances, it can lead to complications such as portal hypertension. Monitoring and managing the condition is crucial to prevent further liver damage and complications.

Portal Hypertension – This condition occurs when there is increased blood pressure within the portal venous system, which carries blood from the digestive organs to the liver. It is often a result of liver cirrhosis or other liver diseases that cause scarring and obstruction of blood flow. The increased pressure can lead to the development of varices, which are enlarged veins that can rupture and bleed. Other complications may include ascites, which is the accumulation of fluid in the abdominal cavity. Managing portal hypertension is important to reduce the risk of serious complications.

Trial ID:

2024-513351-33-00

Protocol code:

TECA

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Telmisartan for Reducing Portal Hypertension in Patients with Advanced Chronic Liver Disease

What is this study about?

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