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Study on the Effect of Landiolol Hydrochloride and Sodium Chloride in Patients Experiencing Cardiac Arrest

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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 the effects of a treatment for patients who have experienced a cardiac arrest, specifically those with a type of irregular heart rhythm known as ventricular fibrillation. The treatment being tested is a medication called landiolol hydrochloride, which is a type of drug known as a beta-blocker. Beta-blockers are commonly used to manage heart conditions by slowing down the heart rate and reducing blood pressure. In this study, landiolol hydrochloride is being compared to a placebo to see if it can help improve the chances of the heart starting to beat on its own again after a cardiac arrest.

The purpose of the study is to find out if adding landiolol hydrochloride to the standard treatment for cardiac arrest can decrease the time it takes for the heart to achieve a sustained return of spontaneous circulation (sROSC), which means the heart starts beating effectively on its own. Participants in the study will receive either the landiolol hydrochloride or a placebo through an intravenous injection, which means the medication is given directly into a vein. The study will monitor how quickly the heart starts beating again and will also look at other outcomes, such as survival after 24 hours and the patient's neurological condition.

In addition to landiolol hydrochloride, the study involves the use of sodium chloride solution, which is a common fluid used in medical settings to help deliver medications intravenously. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo, ensuring unbiased results. The trial aims to provide valuable information on whether landiolol hydrochloride can be an effective addition to the treatment of cardiac arrest, potentially improving outcomes for patients experiencing this life-threatening condition.

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 trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will be asked to provide consent to participate in the trial.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying that you are 18 years or older and have experienced three or more shockable rhythms, such as ventricular fibrillation, with the last rhythm being shockable.

  3. Step 3

    Treatment administration

    You will receive the study medication, which includes landiolol hydrochloride and sodium chloride. The medication will be administered through an intravenous injection or intravenous infusion. The dosage and frequency will be determined by the medical team based on the study protocol.

  4. Step 4

    Monitoring and observation

    After receiving the medication, you will be closely monitored to assess the time it takes to achieve a sustained return of spontaneous circulation (sROSC). This involves continuous observation of your heart rhythm and vital signs.

  5. Step 5

    Follow-up assessments

    Follow-up assessments will be conducted to evaluate cumulative return of spontaneous circulation (ROSC), temporary ROSC, sustained ROSC, survival at 24 hours, and neurological outcomes. These assessments help determine the effectiveness of the treatment.

  6. Step 6

    Completion of trial participation

    Your participation in the trial will conclude once all necessary data has been collected and analyzed. You will be informed about the results and any further steps if applicable.

Who can join the trial?

5 criteria

  • Must have experienced an out-of-hospital cardiac arrest (OHCA). This means the heart stopped beating effectively outside of a hospital setting.
  • Must be 18 years of age or older.
  • Must have had 3 or more shockable heart rhythms. These are specific types of irregular heartbeats that can be treated with an electric shock. The types include ventricular fibrillation (VF) and pulseless ventricular tachycardia (pVT).
  • The last recorded heart rhythm before treatment must be one that is shockable.
  • Both men and women can participate.

Who cannot join the trial?

1 criterion

  • Patients who have experienced a cardiac arrest (when the heart suddenly stops beating) or ventricular fibrillation (a type of irregular heart rhythm) cannot participate.
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Investigated drugs

Landiolol is a medication used in this clinical trial. It is a type of drug known as a beta-blocker. Beta-blockers help to slow down the heart rate and reduce the heart's workload. In this trial, landiolol is being tested to see if it can help patients who have experienced a cardiac arrest. The goal is to find out if landiolol can help these patients by decreasing the time it takes for their heart to start beating effectively again after receiving the medication. This is important because a quicker recovery of heart function can improve the chances of survival and recovery after a cardiac arrest.

What is already known about the treatment

Landiolol – Landiolol is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently being studied in clinical trials for its potential use in treating cardiac arrest, specifically in cases of ventricular fibrillation. The main therapeutic indication for landiolol is to help restore normal heart rhythm in patients experiencing cardiac arrest. At the molecular level, landiolol works by blocking certain receptors in the heart, known as beta-adrenergic receptors, which helps to slow down the heart rate and stabilize heart rhythm. It is classified as a beta-blocker, a type of medication commonly used to manage heart conditions.

Investigated diseases

  • Cardiac Arrest

    Cardiac arrest is a sudden loss of heart function, leading to a stop in effective blood circulation. It occurs when the heart's electrical system malfunctions, causing an irregular heartbeat or arrhythmia. This condition results in the heart being unable to pump blood to the brain, lungs, and other organs. Without immediate intervention, cardiac arrest can lead to loss of consciousness and cessation of breathing. The progression is rapid, and immediate medical attention is crucial to restore normal heart function. It is often associated with ventricular fibrillation, a specific type of arrhythmia.

  • Ventricular Fibrillation

    Ventricular fibrillation is a severe cardiac rhythm disturbance where the heart's ventricles quiver instead of contracting properly. This erratic electrical activity prevents the heart from pumping blood effectively, leading to a rapid drop in blood pressure and loss of consciousness. It is a life-threatening condition that can result in cardiac arrest if not treated immediately. The heart's inability to pump blood can cause vital organs to be deprived of oxygen. Ventricular fibrillation often requires emergency medical intervention to restore a normal heart rhythm. It is characterized by chaotic and irregular heartbeats.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518949-14-00Estimated enrolment48 patientsSponsorMedical University Of Vienna

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