AuthorisedTherapeutic confirmatory (Phase III)Interventional

LEONARD.LEvOsimendaN vs. Placebo Before Tricuspid VAlve Surgery in Patients with Right Ventricular Dysfunction (LEONARD)

This study, called LEONARD, is investigating a medicine named levosimendan for patients having surgery to fix a leaky valve in their heart (tricuspid valve). When this valve doesn't work well, it can put a strain on the right side of the heart. The study wants to find out if using levosimendan before surgery can prevent serious issues in the 90 days following the operation. These serious issues include things like the heart not pumping enough blood, needing special machines to help the heart or kidneys, or needing medication to keep blood pressure up for a long time. Half the patients will receive levosimendan, and the other half will get a dummy treatment (placebo) to see if the drug makes a difference.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

230

Start

03 Dec 2024

Patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid regurgitation

What is this study about?

The LEONARD study is looking into whether a particular medicine, called levosimendan, can help people who are having surgery for a specific heart condition. This condition involves one of the heart's valves, called the tricuspid valve, not closing properly, leading to what doctors call 'tricuspid regurgitation'. If this valve is very leaky, it can make your heart work harder than it should.

Researchers want to see if giving levosimendan before this surgery can prevent serious problems that can sometimes happen in the first three months after a big heart operation. These problems can include the heart not being able to pump enough blood around the body (known as low cardiac output syndrome), needing help from machines, or requiring strong medications to support the heart and blood pressure. By studying this, doctors hope to find better ways to help patients recover more smoothly after heart surgery.

This study is a 'Phase III' clinical trial, which means it's one of the final steps before a new treatment might become widely available. It's designed to confirm if levosimendan is both effective and safe for this specific use. Your participation would help doctors understand more about improving outcomes for patients undergoing tricuspid valve surgery.

Key takeaways

The LEONARD study investigates a drug (levosimendan) for patients having heart valve surgery.
It aims to reduce serious problems like a weak heart after surgery.
Participants will receive either the study drug or a dummy treatment.
The study monitors recovery for 90 days post-surgery.
Your involvement helps improve future care for heart surgery patients.

Who may be eligible?

To be considered for this study, you need to be an adult (18 years or older).

The main requirement is that you are scheduled to have surgery to fix a problem with your tricuspid heart valve. This could be where only the tricuspid valve is being repaired, or if it's being fixed at the same time as other heart problems.

Your medical team will check your full health history to make sure this study is the right fit for you. They will explain if there are any reasons why you might not be able to take part.

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?
Are you scheduled for surgery on your tricuspid heart valve?
Do you understand that you might receive a placebo (dummy treatment)?
Are you able to attend follow-up appointments for 90 days after surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the LEONARD study, you would be randomly assigned to receive either the study drug, levosimendan, or a dummy treatment (placebo) before your tricuspid valve surgery. Neither you nor your doctors will know which treatment you are receiving. The medicine would be given through a drip.

After your surgery, the research team will closely monitor your recovery in the hospital. They will keep track of how your heart is working, your blood pressure, and whether you need any extra support like certain medicines or machines. You will have follow-up assessments for up to 90 days (about three months) after your surgery to check on your health and recovery. The total duration of your participation would be from shortly before your surgery until the 90-day follow-up.

Potential risks and benefits

Taking part in this study could potentially help improve recovery after tricuspid valve surgery, not just for you but for future patients too. However, there's no guarantee the study drug will specifically benefit you. As with any medication, there are potential side effects, which your medical team will discuss in detail. You might also experience some inconvenience due to extra monitoring or appointments. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your 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
France

Common questions

What is levosimendan?

Levosimendan is a medication that helps the heart pump more effectively and can also widen blood vessels, which helps blood flow more easily.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the study drug but contains no active medicine. It helps researchers compare if the drug is actually making a difference.

What is 'tricuspid valve surgery'?

This is an operation to fix a valve on the right side of your heart that isn't working properly, often because it's leaky.

What does 'low cardiac output syndrome' mean?

It means your heart isn't pumping enough blood to meet your body's needs, which can be a serious problem after heart surgery.

Will I know if I'm getting the study drug or the placebo?

No, this study is 'blinded,' meaning neither you nor your doctors will know which treatment you are receiving until after the study is complete, unless there's a medical emergency.