AuthorisedPhase III and phase IV (Integrated)Interventional

LEVOMEMS: Comparison of the Hemodynamic Profile of Dobutamine and Levosimendan in the Current Therapeutic Context

This important study, called LEVOMEMS, is looking at two medicines, dobutamine and levosimendan, which are used to help people with heart failure. Heart failure means your heart isn't pumping blood as well as it should. The study aims to find out if one medicine is better than the other at improving how your heart and lungs work. Doctors will be checking things like the pressure in your lungs and how much blood your heart pumps after three months. They'll also look at how these medicines affect your quality of life and general health, including blood tests and how well you can walk. The goal is to improve care for people living with this condition.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol

Enrolment target

Start

03 Dec 2024

Heart failure patients with depressed left ventricular ejection fraction

What is this study about?

This research, known as LEVOMEMS, is a study comparing two medicines, dobutamine and levosimendan, which are currently used to treat heart failure. Heart failure is a condition where your heart muscle doesn't pump blood as effectively as it should, leading to symptoms like shortness of breath and tiredness. Both dobutamine and levosimendan are given to help the heart pump stronger.

The main goal of this study is to understand how these two medicines affect the heart and lungs in people with heart failure. Specifically, after three months, doctors will measure the pressure inside the lungs and how much blood the heart is pumping with each beat. These measurements are important indicators of how well your heart is working and how your body is responding to the treatment.

The study will also look at several other aspects of your health. This includes checking if you need to be readmitted to the hospital for heart failure, how your overall quality of life changes (using special questionnaires), and how far you can walk in six minutes. Researchers will also perform blood tests to look at specific markers related to heart health, check for fluid in the lungs using an ultrasound, and monitor kidney function. By gathering all this information, doctors hope to gain a clearer picture of which medicine might be more beneficial for patients like you.

Key takeaways

This study compares two heart failure medicines: dobutamine and levosimendan.
It aims to see which medicine helps the heart and lungs work better.
Researchers will monitor heart function, quality of life, and overall health.
Adults with a specific type of heart failure may be eligible.
Participation involves monitoring and assessments over several months.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years and older, who have heart failure. Both men and women are welcome to take part.

To be eligible, you need to have a specific type of heart failure where your heart's main pumping chamber (the left ventricle) isn't squeezing as strongly as it should. This is often referred to as having a 'depressed left ventricular ejection fraction'.

There might be other health conditions or medicines that would prevent you from joining, but the research team will discuss all of these details with you to make sure the study is a safe and suitable option for your unique situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with heart failure?
Has your doctor told you that your heart's main pumping chamber (left ventricle) isn't squeezing well?
Are you able to attend regular appointments for assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either dobutamine or levosimendan as your treatment. This would involve regular visits to the hospital or clinic where the research team would monitor your progress. They would take measurements of your heart and lung function, conduct blood tests, and ask you to fill out questionnaires about your quality of life. You would also perform a simple walking test. These assessments would happen at the beginning of the study and then again at the end of each treatment period, and at the 3-month mark to track changes. The study involves taking one of these medications, and you will be closely monitored for any side effects.

Potential risks and benefits

Participating in research studies like this can offer several potential benefits. For example, you would receive close medical attention and monitoring from a specialist team. You might also gain access to medicines that are being closely studied to improve heart failure care. However, like all medicines, dobutamine and levosimendan can have side effects. The research team will carefully explain the known risks associated with each drug, such as changes in blood pressure or heart rhythm, and will monitor you closely for any unwanted effects. It's very important to remember that participating in any clinical trial is entirely voluntary, and you have the right to withdraw at any time without giving a reason, and without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood around your body as well as it should. It can make you feel tired or short of breath.

What are dobutamine and levosimendan?

These are two different medicines given to help your heart pump more strongly if you have heart failure.

What is a 'Phase III and IV' study?

This means the medicines are already approved for use, but doctors are looking closely at how they work in real-world settings and comparing them for better care.

Will I know which medicine I'm getting?

The research team will explain how the medicines are given and whether you will know which one you are receiving.

What is 'quality of life' in this study?

The study will use questionnaires to understand how your health and treatment affect your daily life and how you feel overall.