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Study on Esmolol for Heart Issues in Patients with Cirrhosis, Diabetes, or Cardiotoxic Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying cardiovascular disorders that can occur in people with certain conditions such as cirrhosis, diabetes mellitus, and those undergoing cardiotoxic treatments for cancer. The treatment being tested in this study is a medication called esmolol, which is given as a solution for infusion. The purpose of the study is to evaluate how effective esmolol is in identifying early signs of heart problems in these patients.

Participants in the study will receive esmolol, and their heart function will be monitored using a special type of heart imaging called echocardiography. This imaging technique helps doctors see how well the heart is working. The study aims to compare the results of echocardiography with and without esmolol to see if esmolol provides better information about the heart's condition. The study will involve 1,000 patients who will be divided into different groups based on their specific health conditions.

Throughout the study, researchers will look at various heart function measurements and blood tests to understand how esmolol affects the heart. They will also assess whether esmolol can help predict future heart problems in patients with diabetes, cirrhosis, or those receiving cancer treatments. The study will help determine if esmolol can be a useful tool in diagnosing and managing heart issues in these patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older), absence of previous heart disease, and a suitable ultrasound window for heart imaging.

    Participants must have a sinus rhythm with a resting heart rate above 50 beats per minute.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements of heart function using echocardiography, a type of ultrasound that creates images of the heart.

    This assessment helps in understanding the current state of heart function before any treatment is administered.

  3. Step 3

    Administration of <b>esmolol</b>

    Esmolol is administered as a solution for infusion, which means it is given through a vein.

    The purpose of administering esmolol is to evaluate its effectiveness in identifying heart problems early, especially those related to conditions like cirrhosis, diabetes, and treatments that may harm the heart.

  4. Step 4

    Follow-up assessments

    After the administration of esmolol, follow-up assessments are conducted to measure changes in heart function.

    These assessments compare the heart's performance before and after esmolol administration to determine its impact.

  5. Step 5

    Long-term monitoring

    Participants are monitored over a period of time to observe any long-term effects of esmolol on heart function.

    The study aims to predict the occurrence of major heart events, such as heart failure or cardiovascular death, over a three-year follow-up period.

  6. Step 6

    Completion of the study

    The study is expected to conclude by December 31, 2025.

    Final results will be analyzed to determine the effectiveness of esmolol in diagnosing and predicting heart problems in patients with specific conditions.

Who can join the trial?

4 criteria

  • Must be **18 years or older**.
  • Must not have any previous **heart disease**. This means no significant changes in the heart's structure, like moderate or severe thickening of the heart muscle, problems with heart valves, blocked heart chambers, or past heart attacks.
  • Must have a good **ultrasound window**. This means the heart ultrasound should clearly show at least 14 out of 17 parts of the heart's left side.
  • Must have a normal heart rhythm called **sinus rhythm**, with a resting heart rate above 50 beats per minute.

Who cannot join the trial?

3 criteria

  • Patients with heart problems caused by **cirrhosis**. Cirrhosis is a condition where the liver is damaged and scarred.
  • Patients with heart problems caused by **diabetes mellitus**. Diabetes mellitus is a condition where the body has trouble controlling blood sugar levels.
  • Patients with heart problems caused by **cardiotoxic treatments**. Cardiotoxic treatments are medical treatments that can harm the heart.
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Investigated drugs

Esmolol is a medication used in this clinical trial to help identify early signs of heart problems that may be caused by conditions like cirrhosis, diabetes, and certain cancer treatments. The study aims to see if using esmolol during heart imaging tests (echocardiography) is better at detecting these issues compared to standard heart imaging methods.

What is already known about the treatment

Esmolol – Esmolol is administered intravenously and is used primarily in hospital settings. It is currently being studied in clinical trials to assess its effectiveness in identifying cardiovascular disorders caused by conditions such as cirrhosis, diabetes, and cardiotoxic treatments. The main therapeutic use of esmolol is to manage heart rate and blood pressure in acute situations. At the molecular level, esmolol works by blocking beta-adrenergic receptors, which reduces the effects of adrenaline on the heart, leading to decreased heart rate and blood pressure. It is classified as a beta-blocker, a type of medication commonly used to treat cardiovascular conditions.

Investigated diseases

  • Cirrhosis

    Cirrhosis is a chronic liver disease characterized by the replacement of healthy liver tissue with scar tissue, which impairs liver function. Over time, this scarring can lead to liver failure as the liver becomes unable to perform its vital functions. The disease progresses slowly and may initially present with few symptoms, but as it advances, symptoms such as jaundice, fatigue, and swelling in the legs and abdomen may occur. Cirrhosis can result from various causes, including chronic alcohol abuse, hepatitis infections, and fatty liver disease. As the liver becomes more damaged, complications such as portal hypertension and liver cancer may develop.

  • Diabetes Mellitus Type 2

    Diabetes Mellitus Type 2 is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, leading to elevated blood sugar levels. Over time, high blood sugar can cause serious health issues, including heart disease, nerve damage, and kidney problems. The disease often develops gradually and may initially be managed with lifestyle changes, but it can progress to require medication or insulin therapy. Common symptoms include increased thirst, frequent urination, and unexplained weight loss.

  • Cardiotoxicity

    Cardiotoxicity refers to damage to the heart muscle caused by harmful substances, often as a side effect of certain cancer treatments. This condition can lead to a decrease in the heart's ability to pump blood effectively, potentially resulting in heart failure. Symptoms may include shortness of breath, fatigue, and swelling in the legs and ankles. The progression of cardiotoxicity can vary depending on the type and dosage of the treatment received. Monitoring heart function during and after treatment is crucial to detect and manage any cardiac issues early.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514880-25-00Protocol codeCIBER-bB-ECHOEstimated enrolment1 000 patientsSponsorConsorcio Centro De Investigacion Biomedica En Red

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