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A study testing landiolol in patients with ST-elevation acute coronary syndrome undergoing primary percutaneous coronary intervention

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What is this trial about?

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

This study examines ST-elevation acute coronary syndrome, which is a serious type of heart attack that occurs when blood flow to part of the heart muscle is suddenly blocked. The study will use Landiolol, a medication that belongs to a group of medicines called beta-blockers, which work by slowing down the heart rate and reducing the strain on the heart. Some participants will receive Landiolol while others will receive placebo. The purpose of the study is to evaluate whether it is possible to give Landiolol continuously through a vein very early in patients with this type of heart attack who are undergoing a procedure to open blocked heart arteries.

Participants in this study will have experienced a heart attack affecting the front or side wall of the heart. They will be treated at the study center and must be stable enough to participate, meaning their blood pressure and heart rate are within certain ranges. The study medication will be given through a vein continuously for 24 hours, starting before the procedure to open the blocked arteries and continuing during and after the procedure. The main goal is to see how many enrolled patients can receive the full 24-hour infusion of Landiolol with no single break longer than one hour.

During the study, doctors will closely monitor participants for any irregular heart rhythms, changes in heart function, and blood pressure. Blood tests will be taken at different times to measure substances that indicate heart damage and function. Heart activity will be monitored using electrocardiograms at admission and at regular intervals up to 90 days. An ultrasound examination of the heart will be performed to measure how well the heart is pumping at the beginning of the study and again after 90 days. The study will also track any heart-related problems, hospital readmissions, and overall health outcomes for up to six months after treatment.

The research process

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

Step 1
Initial assessment and treatment start
Upon joining the study, your condition will be assessed to confirm that you are stable enough to receive the study treatment. This includes checking that your blood pressure is adequate (mean arterial pressure above 60 mmHg) and your heart rate is above 70 beats per minute.
You will receive either landiolol hydrochloride (the study medication) or a placebo (an inactive substance) through an intravenous infusion (a drip into your vein). The study is double-blinded, which means neither you nor your doctors will know which treatment you are receiving during the study period.
The infusion will begin before your heart procedure and will continue throughout the procedure.
Step 2
Continuous infusion period
The intravenous infusion will continue for a total of 24 hours without interruption, or with only brief interruptions of less than 1 hour if necessary.
During this time, your heart rate, blood pressure, and overall condition will be monitored regularly to ensure your safety.
Blood samples will be taken to measure specific substances in your blood that indicate heart function. These measurements will occur at the following times: when you are admitted, after 6 hours, after 12 hours, after 18 hours, and after 24 hours.
Step 3
End of infusion and immediate monitoring
After 24 hours, the intravenous infusion will be stopped.
Your medical team will continue to monitor your heart rhythm, blood pressure, and overall condition to check for any changes or complications.
Additional blood samples may be collected, and your heart's electrical activity will be assessed using an electrocardiogram (a test that records the electrical signals of your heart).
Step 4
Hospital stay and echocardiography
Within 48 hours of admission, you will undergo an echocardiography (an ultrasound examination of your heart) to evaluate how well your heart is pumping blood. This measurement is called the left ventricular ejection fraction.
Your doctors will continue to monitor your recovery and watch for any heart-related complications during your hospital stay.
Step 5
Follow-up at 90 days
Approximately 90 days (3 months) after your initial treatment, you will return for a follow-up visit.
During this visit, you will have another echocardiography to assess any changes in your heart's pumping function compared to the initial measurement.
Blood samples will be taken again to measure heart function markers.
Your doctor will review your overall health and check whether you have experienced any heart-related problems or hospital readmissions since your initial treatment.
Step 6
Follow-up at 6 months
At 6 months after your initial treatment, your medical team will assess your overall health status.
This assessment will include checking whether you have experienced any major heart or blood vessel complications, such as another heart attack, stroke, heart failure, or need for additional heart procedures.
Your survival and general health status will be documented as part of the study's long-term evaluation.

Who can join the trial?

4 criteria

You must have a type of heart attack called anterior or lateral ST-elevation acute coronary syndrome, which means you have a specific pattern on your heart tracing test showing that the front or side part of your heart is not getting enough blood flow
You must be at least 18 years old
Your blood pressure and heart function must be stable, meaning your mean arterial pressure (average blood pressure in your arteries) must be greater than 60 mmHg and your heart rate (how fast your heart beats) must be greater than 70 beats per minute
You must be able to understand the study information and provide your agreement to participate by signing a consent form

Who cannot join the trial?

1 criterion

No exclusion criteria have been specified in the available study information

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Klinik Landstrasse
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Vienna, Austria

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Investigated drugs

Landiolol is a medication that belongs to a group of medicines called beta-blockers. It works by slowing down the heart rate and reducing the force of the heart's contractions. This helps to decrease the workload on the heart and reduce its demand for oxygen. In this trial, Landiolol is given through a vein as a continuous infusion to patients who are having a heart attack to see if it can help protect the heart muscle during treatment.

What is already known about the treatment

Landiolol – Landiolol is a highly cardioselective beta-blocker medication that is given through continuous intravenous infusion, meaning it is delivered directly into the bloodstream through a vein over an extended period. This medication is being studied for use in patients experiencing ST-elevation acute coronary syndrome, which is a severe type of heart attack where blood flow to the heart muscle is suddenly blocked. Landiolol works at the molecular level by selectively blocking beta-1 receptors in the heart, which helps slow down the heart rate and reduce the heart's workload during the critical period of a heart attack. It belongs to the pharmacological class of ultra-short-acting beta-blockers and is being evaluated in clinical trials to determine if early administration during emergency heart procedures can improve patient outcomes.

Investigated diseases

ST-Elevation Acute Coronary Syndrome – This is a serious type of heart attack that occurs when a coronary artery becomes completely blocked, preventing blood flow to a portion of the heart muscle. The blockage is usually caused by a blood clot that forms on top of a ruptured fatty deposit in the artery wall. On an electrocardiogram, this condition shows a characteristic pattern with elevated ST segments, which gives the condition its name. Without prompt restoration of blood flow, the affected heart muscle begins to die within minutes to hours. The condition typically affects the anterior or lateral walls of the heart. Patients commonly experience severe chest pain, shortness of breath, sweating, and nausea.