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Study on the Effects of Dobutamine and Levosimendan in Patients with Heart Failure and Reduced Left Ventricular Function

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 clinical trial is focused on studying the effects of two medications, dobutamine and levosimendan, in the treatment of heart failure. Heart failure is a condition where the heart is unable to pump blood effectively, leading to symptoms like shortness of breath and fatigue. The study specifically looks at patients with a reduced ability of the heart's left ventricle to pump blood, known as depressed left ventricular ejection fraction.

The purpose of the study is to compare how these two medications affect the heart and blood vessels. Participants will receive either dobutamine or levosimendan, both administered intravenously, meaning they are given directly into a vein. The study will observe changes in the pressure within the lungs' blood vessels and the amount of blood the heart pumps. These observations will help understand how each medication works in the current treatment context for heart diseases.

Throughout the study, participants will be monitored for various health indicators, including heart function and overall well-being. The study will last for a period of time, during which participants will have regular check-ups to assess their heart's performance and any side effects from the medications. The goal is to gather information that could improve treatment options for people with heart failure.

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

    Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

    You must meet certain criteria to participate, including being over 18 years old and having a specific heart condition with a reduced heart function.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current health status. This includes measuring your heart's pumping ability and other health parameters.

    You will undergo tests such as echocardiography, which uses sound waves to create images of your heart.

  3. Step 3

    Medication administration

    You will receive one of two medications: dobutamine hydrochloride or levosimendan. Both are administered through an intravenous route, meaning they are given directly into your bloodstream.

    The dosage and frequency of administration will be determined by the study team based on your specific needs and health status.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes regular checks of your heart function and blood pressure.

    You will be asked to complete quality of life assessments and participate in physical tests, such as a 6-minute walk test, to evaluate your physical capabilities.

  5. Step 5

    End of study evaluation

    At the end of the study period, a final evaluation will be conducted to assess the effects of the medication on your heart condition.

    This will include measuring changes in your heart's pumping ability and any other health parameters that were monitored during the study.

Who can join the trial?

5 criteria

  • Must be over 18 years old.
  • Have a left ventricular ejection fraction (LVEF) of less than 35% as shown by an echocardiogram (a heart ultrasound) in the last 6 months.
  • Be in NYHA functional class III or higher, which means experiencing significant limitations in physical activity due to heart failure, even after receiving the best possible treatment and using diuretics (medications that help remove excess fluid from the body).
  • Have had a recent hospital admission or outpatient treatment for heart failure worsening, requiring diuretics in the last six months, which leads to the need for a CardioMEMS device (a device that monitors heart pressure).
  • Must sign an informed consent form, which means agreeing to participate in the study after understanding all the details and risks involved.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with heart failure with a depressed left ventricular ejection fraction cannot participate. This means the heart is not pumping blood as well as it should.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This includes groups that may need special protection in research.
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Investigated drugs

  • Dobutamine

    is a medication used to help the heart pump blood more effectively. It is often given to patients who have heart problems and need support to improve their heart's ability to circulate blood. In this trial, dobutamine is being studied to see how it affects the pressure in the lungs and the amount of blood the heart can pump.

  • Levosimendan

    is a medication that helps the heart work better by making it stronger and more efficient. It is used for patients with heart failure to improve their heart function. In this study, levosimendan is being tested to understand its impact on lung pressure and the heart's blood-pumping ability, comparing it to the effects of dobutamine.

What is already known about the treatment

  • Levosimendan

    Levosimendan is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently being studied for its effects on heart failure patients with a weakened heart muscle. The main therapeutic use of Levosimendan is to help improve heart function in these patients. It works by increasing the sensitivity of the heart muscle to calcium, which helps the heart pump more effectively without using more energy. Levosimendan is classified as a calcium sensitizer and inotropic agent, which means it helps strengthen the heart's contractions.

  • Dobutamine

    Dobutamine is also administered intravenously, allowing it to be delivered directly into the bloodstream. It is used in the treatment of heart failure, particularly in patients with reduced heart muscle function. The primary therapeutic indication for Dobutamine is to enhance the heart's pumping ability. It acts by stimulating the heart's beta-1 adrenergic receptors, leading to increased heart muscle contraction and improved blood flow. Dobutamine is classified as a beta-adrenergic agonist and inotropic agent, which helps boost the heart's performance.

Investigated diseases

Heart Failure with Reduced Ejection Fraction – This condition occurs when the heart muscle is unable to pump blood effectively, leading to a decrease in the amount of blood ejected from the left ventricle with each heartbeat. Over time, the heart's ability to pump diminishes, causing blood to back up in the lungs and other parts of the body. This can result in symptoms such as shortness of breath, fatigue, and fluid retention. As the disease progresses, the heart may become enlarged, and the walls of the heart chambers may thicken. The reduced ejection fraction indicates a weakened heart muscle, which can lead to further complications if not managed. The progression of this condition can vary, but it generally involves a gradual worsening of symptoms and heart function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519631-42-00Protocol codeLEVOMEMSEstimated enrolment10 patientsSponsorInstituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol

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