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Study on the Use of Landiolol Hydrochloride and Sodium Chloride for Patients Undergoing Mitral Valve Surgery to Prevent Low-Cardiac Output Syndrome

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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 medication called landiolol hydrochloride in patients undergoing surgery for the mitral valve, which is a valve in the heart. The trial aims to see if this medication can help reduce the chances of developing a condition known as Low-Cardiac Output Syndrome (LCOS) after surgery. LCOS is a situation where the heart does not pump enough blood to meet the body's needs, which can happen after heart surgery.

In this study, participants will receive either the medication Landiobloc, which contains landiolol hydrochloride, or a placebo. Landiolol hydrochloride is a type of medication known as a beta-blocker, which helps to slow down the heart rate and reduce the heart's workload. The study will also use a solution called sodium chloride, commonly known as saline, which is often used in medical settings to provide fluids and electrolytes.

The purpose of the study is to determine if landiolol hydrochloride can effectively reduce the occurrence of LCOS after mitral valve surgery. Participants will be randomly assigned to receive either the medication or a placebo during their surgery. The study will monitor the participants' heart function and recovery after surgery to assess the effects of the treatment. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, ensuring unbiased results.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing an informed consent form, confirming understanding and agreement to the trial's terms.

    Eligibility is confirmed based on criteria such as age over 18, undergoing specific mitral valve surgery, and certain heart measurements.

  2. Step 2

    Pre-surgery preparation

    Preparation for elective mitral valve repair or replacement surgery is conducted.

    The surgery involves a planned cardiopulmonary bypass, which is a technique that temporarily takes over the function of the heart and lungs during surgery.

  3. Step 3

    Administration of study medication

    During surgery, a medication called landiolol hydrochloride is administered as an adjuvant to cardioplegia, which is a method used to protect the heart during surgery.

    The medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream.

  4. Step 4

    Post-surgery monitoring

    After surgery, monitoring for low-cardiac output syndrome (LCOS) is conducted. This condition involves the heart not pumping enough blood to meet the body's needs.

    The primary goal is to reduce the occurrence of LCOS, which may require prolonged catecholamine infusion, mechanical assist devices, or renal replacement therapy.

  5. Step 5

    Follow-up assessments

    Secondary outcomes include monitoring for prolonged catecholamine infusion, increased cardiac biomarkers, changes in heart function, hospital readmissions, and overall health status using the EQ-5D-5L questionnaire.

    The trial also tracks any occurrences of death related to the condition.

Who can join the trial?

8 criteria

  • Must be **older than 18 years**.
  • Must be **undergoing elective mitral valve repair or replacement surgery**. This means the surgery is planned in advance and is not an emergency.
  • The surgery must involve a **planned cardiopulmonary bypass**. This is a machine that takes over the function of the heart and lungs during surgery.
  • The surgery must be done through a **midline sternotomy** or **minithoracotomy**. These are types of surgical approaches to access the heart.
  • Must have **preoperative evidence** of certain heart measurements:
    • **Left ventricular end-systolic diameter** greater than 40 mm. This is a measurement of the heart's left ventricle size when it is contracted.
    • **Left ventricular end-diastolic diameter** greater than 60 mm. This is a measurement of the heart's left ventricle size when it is relaxed.
    • **Left ventricular ejection fraction** less than 60%. This is a measure of how well the heart is pumping blood.
    • Must have **signed informed consent**. This means you agree to participate in the study after being informed about it.
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Investigated drugs

Landiolol is a medication being studied in this trial. It is used as an adjuvant, which means it is added to enhance the effect of another treatment. In this case, landiolol is used during mitral valve surgery to help protect the heart. The goal is to see if it can reduce the chances of developing a condition called low-cardiac output syndrome after surgery. This condition occurs when the heart doesn't pump enough blood to meet the body's needs, and the study is investigating whether landiolol can help prevent this from happening.

What is already known about the treatment

Landiolol – Landiolol is administered intravenously, typically during surgical procedures, to manage heart conditions. It is currently being studied in clinical trials, such as the LUNA trial, to evaluate its effectiveness in reducing postoperative low-cardiac output syndrome, particularly in mitral valve surgery. The medication works by slowing down the heart rate and reducing the heart's workload, which helps improve cardiac output. Landiolol is classified as a beta-blocker, a type of medication that affects the heart and circulation.

Investigated diseases

Low-cardiac output syndrome – This condition occurs when the heart is unable to pump enough blood to meet the body's needs, often following cardiac surgery. It can lead to symptoms such as fatigue, shortness of breath, and reduced exercise tolerance. The syndrome may develop due to weakened heart muscle, valve problems, or complications from surgery. Patients may require medications to support heart function or mechanical devices to assist circulation. The condition is typically monitored in a hospital setting, especially in intensive care units. It is important to manage this syndrome promptly to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515934-34-00Protocol codeLUNAEstimated enrolment1 500 patientsSponsorOspedale San Raffaele S.r.l.

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