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Study on the Early Use of Levosimendan Compared to Placebo for Patients with Cardiogenic Shock

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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 levosimendan in patients experiencing cardiogenic shock. Cardiogenic shock is a serious condition where the heart suddenly can't pump enough blood to meet the body's needs. The study aims to evaluate how early use of levosimendan, compared to a placebo, affects the health outcomes of these patients. Levosimendan is a medication that helps the heart pump more effectively, and it is given through an intravenous infusion, which means it is delivered directly into the bloodstream.

Participants in the study will receive either levosimendan or a placebo, in addition to the standard treatment they are already receiving for their condition. The study will monitor the participants over a period of time to see if there are any differences in outcomes such as survival rates, the need for additional life support, or dialysis, which is a treatment that helps clean the blood when the kidneys are not working properly. The goal is to determine if levosimendan can improve the overall health and recovery of patients with cardiogenic shock.

The study will follow participants for up to 30 days initially, with additional follow-ups at 90 days, 180 days, and 12 months to assess long-term effects. Researchers will look at various health indicators, including the number of days patients are free from certain medications, the length of hospital stays, and any major cardiovascular events like heart attacks or strokes. This information will help determine the effectiveness and safety of levosimendan in treating cardiogenic shock.

The research process

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

Step 1
Joining the study
Upon joining the study, the patient is randomly assigned to receive either levosimendan or a placebo. This is done to compare the effects of the medication with no active treatment.
The study focuses on patients experiencing cardiogenic shock, a condition where the heart suddenly cannot pump enough blood to meet the body's needs.
Step 2
Treatment administration
The patient receives the assigned treatment through an intravenous infusion. This involves administering the medication directly into the bloodstream.
The medication used in the study is ZIMINO 2.5 mg/ml, a solution prepared for infusion.
Step 3
Monitoring and evaluation
Throughout the study, the patient's health is closely monitored. This includes checking vital signs and assessing the heart's ability to pump blood effectively.
The primary goal is to observe the effects of the treatment on 30-day mortality and the need for additional support like ExtraCorporeal Life Support (ECLS) or dialysis.
Step 4
Follow-up assessments
Follow-up assessments occur at various intervals, including days 7, 30, 60, 90, 180, and 12 months after starting the treatment.
These assessments evaluate the patient's overall health, including any major cardiovascular events, the need for further medical interventions, and the duration of hospital stays.
Step 5
Study completion
The study is expected to conclude by July 3, 2027. At this point, all data collected will be analyzed to determine the effectiveness of levosimendan compared to the placebo.
The results will help understand the potential benefits of early use of levosimendan in treating cardiogenic shock.

Who can join the trial?

5 criteria

Must be an adult who is 18 years or older and has cardiogenic shock.
Must have an adequate intravascular volume, meaning enough fluid in the blood vessels.
Must be receiving norepinephrine to keep the mean arterial pressure (MAP) at least 65 mmHg for at least 3 hours but less than 24 hours. At the time of joining, the dose should be less than 1 microgram per kilogram per minute if using norepinephrine base, or less than 2 micrograms per kilogram per minute if using norepinephrine tartrate. Alternatively, must be on dobutamine for at least 3 hours but less than 24 hours, with a dose of at least 5 micrograms per kilogram per minute at the time of joining.
Must show signs of tissue hypoperfusion, which means the tissues are not getting enough blood. This can be shown by at least one of the following signs: lactate level of 2 mmol/l or higher, mottling (patchy skin color), capillary refill time longer than 3 seconds, oliguria (low urine output) of less than 500 ml in 24 hours or 20 ml per hour in the last 2 hours, ScVO2 of 60% or less, or a veno-arterial PCO2 gap of 5 mmHg or more.
Must be affiliated with a social security plan.

Who cannot join the trial?

5 criteria

Patients who are not experiencing cardiogenic shock cannot participate. Cardiogenic shock is a condition where the heart suddenly can't pump enough blood to meet the body's needs.
Patients who are under 18 years old or over 65 years old cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Both male and female patients are eligible, but those who do not meet other criteria cannot participate.
Patients who are considered part of a vulnerable population, such as those unable to give informed consent, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Besancon University Hospital Center
Verified
Besançon, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France

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Investigated drugs

Levosimendan is a medication used in this trial to help improve heart function in patients experiencing cardiogenic shock. It works by increasing the strength of the heart's contractions and helping the heart pump more effectively. The study aims to see if using levosimendan early, in addition to standard treatments, can reduce the risk of death or the need for additional support like dialysis or extracorporeal life support within 30 days.

What is already known about the treatment

Levosimendan – Levosimendan is administered intravenously and is currently being studied in clinical trials for its potential benefits in treating cardiogenic shock. It is not yet fully established in medical practice for this condition, but it is gaining attention in medical literature. The main therapeutic indication for levosimendan is to improve heart function in patients experiencing severe heart failure. At the molecular level, it works by increasing the sensitivity of the heart muscle to calcium, which enhances cardiac contractility without significantly increasing oxygen demand. It is classified pharmacologically as a calcium sensitizer and inotropic agent.

Investigated diseases

Cardiogenic Shock – Cardiogenic shock is a serious condition that occurs when the heart suddenly cannot pump enough blood to meet the body's needs. This can result from a severe heart attack or other heart problems that weaken the heart's ability to function. As the heart struggles to pump blood, vital organs may not receive enough oxygen, leading to symptoms like rapid breathing, confusion, and a weak pulse. The condition can progress quickly, causing a drop in blood pressure and reduced blood flow to the organs. Without adequate blood flow, the organs may begin to fail, worsening the patient's condition. Cardiogenic shock requires immediate medical attention to restore blood flow and support heart function.