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Study of Levosimendan Before Tricuspid Valve Surgery in Patients with Right Ventricular Dysfunction

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on patients who need surgery for tricuspid regurgitation, a heart condition where one of the heart valves (the tricuspid valve) doesn't close properly, causing blood to flow backward. The study examines the effectiveness of a medication called levosimendan (ZIMINO) compared to placebo in preventing complications after heart surgery.

The purpose of this research is to determine if giving levosimendan before surgery can help prevent a condition called low cardiac output syndrome, which occurs when the heart cannot pump enough blood to meet the body's needs after surgery. During the study, patients will receive either levosimendan or placebo through an intravenous infusion before their tricuspid valve surgery.

The medication or placebo will be given as a single treatment before the surgery. After the operation, patients will be monitored for 90 days to check for signs of heart-related complications, including the need for additional medications to support heart function, the use of devices to help the heart pump blood, or the need for special treatments to support kidney function.

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

    Initial treatment administration

    You will receive either levosimendan or placebo (5% glucose solution) through an intravenous infusion before your tricuspid valve surgery

    The medical team will administer the treatment in preparation for your surgical procedure

  2. Step 2

    Surgical procedure

    You will undergo surgery to correct your tricuspid valve condition

    The surgical team will perform the necessary corrections to address the moderate to severe tricuspid regurgitation

  3. Step 3

    Post-surgery monitoring - first 48 hours

    The medical team will monitor your heart function

    Your blood pressure and other vital signs will be regularly checked

    The medical staff will assess if you require any additional support medications

  4. Step 4

    Intensive care unit observation

    Your recovery will be closely monitored in the intensive care unit

    The medical team will assess your kidney function and overall recovery progress

    Your heart function will continue to be evaluated

  5. Step 5

    Extended follow-up period

    Your health status will be monitored for a total of 90 days after the surgery

    The medical team will track your recovery progress and any potential complications

    A final assessment will be conducted at the end of the 90-day period

Who can join the trial?

8 criteria

  • Must be 18 years of age or older
  • Must provide written informed consent to participate in the study
  • Must be enrolled in the French healthcare system
  • Must be scheduled for heart surgery to correct moderate to severe tricuspid valve leakage (a condition where the valve between the heart's right chambers doesn't close properly)
  • Must have at least one of these signs of severe tricuspid valve leakage:
    • An effective regurgitant orifice (the size of the leaking area) larger than 20 square millimeters
    • A vena contracta width (the width of the leaking blood flow) greater than 7 millimeters
    • Abnormal blood flow pattern in the liver veins during heart contraction
    • Can be either male or female

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 85 years
  • Severe liver dysfunction (problems with liver function)
  • Severe kidney failure requiring dialysis
  • Known allergic reactions to levosimendan or similar medications
  • Current pregnancy or breastfeeding
  • Unstable heart condition requiring emergency surgery
  • Participation in other clinical trials within the last 30 days
  • Severe low blood pressure (systolic blood pressure below 90 mmHg)
  • Severe heart rhythm disorders that are not controlled by medication
  • History of severe reactions to anesthesia
  • Inability to provide informed consent
  • Significant blood clotting disorders that increase risk of bleeding during surgery
  • Active infection or fever
  • Severe lung disease requiring oxygen therapy
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Investigated drugs

Levosimendan is a medication that helps improve heart function. It works by making the heart muscle contract more strongly and helps blood vessels relax. This medication is given before heart surgery to help prevent complications related to poor heart function, particularly in patients who have problems with their tricuspid valve (one of the heart valves). It's especially useful for patients whose right side of the heart isn't working as well as it should.

What is already known about the treatment

Levosimendan – A calcium sensitizer and inotropic medication administered intravenously that is used in cardiac surgery to improve heart function. This drug works by increasing the sensitivity of heart muscle cells to calcium, thereby enhancing cardiac contractility without significantly increasing oxygen consumption. It is primarily used to prevent low cardiac output syndrome in patients undergoing heart surgery, particularly in cases involving tricuspid valve repair or replacement. Levosimendan belongs to the class of calcium sensitizing agents and has shown promising results in clinical trials for patients with right ventricular dysfunction, especially before tricuspid valve surgery.

Investigated diseases

  • Tricuspid Regurgitation

    A heart valve condition where the tricuspid valve doesn't close properly, causing blood to flow backward into the right atrium when the right ventricle contracts. The condition can range from mild to severe, with moderate to severe cases causing the heart to work harder to pump blood effectively. The condition may develop gradually over time and can be related to other heart problems. When functional in nature, it occurs due to enlargement of the right ventricle or right atrium, rather than from direct valve damage. The condition can lead to fluid retention and decreased cardiac output.

  • Low Cardiac Output Syndrome

    A condition where the heart cannot pump enough blood to meet the body's needs. It is characterized by reduced blood flow from the heart, which can affect multiple organ systems. The condition can develop after heart surgery or in patients with severe heart conditions. The syndrome often requires supportive measures to maintain adequate circulation. It may be accompanied by symptoms such as fatigue, weakness, and decreased urine output.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516167-86-00Protocol codeAPHP200072Estimated enrolment230 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).