Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

CMV preemptive therapy in high-risk immunocompetent major heart surgery patients. A multicenter, double blind, randomized, clinical trial (GAN-CAR).

This study, called GAN-CAR, is for adults having major heart surgery who are at risk of getting a serious infection called Cytomegalovirus (CMV). It's a common virus, but it can cause significant issues after big operations. Researchers want to see if giving certain medications (Ganciclovir or Valganciclovir) can prevent this infection from flaring up and help patients recover faster and more smoothly. The study will look at how many days patients have a 'good outcome' – meaning they are alive, out of intensive care, not needing strong antibiotics or breathing machines, and without serious side effects. They will compare these medicines against a dummy medicine (placebo) to see if they truly make a difference in patient recovery after heart surgery.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon

Enrolment target

226

Start

10 Jan 2023

Cytomegalovirus in high-risk immunocompetent major heart surgery.

What is this study about?

Imagine you're having a big heart operation. Your body is working hard to recover, and sometimes, a very common virus called Cytomegalovirus (CMV) can cause trouble when your immune system is a bit weaker. Most people carry CMV without even knowing it, but after major surgery, it can sometimes become active and make recovery much harder.

This study, called GAN-CAR, is designed to find out if using specific antiviral medicines, Ganciclovir or Valganciclovir, can stop this CMV virus from causing problems after major heart surgery. They want to prevent the virus from becoming active in people who are at a higher risk of complications. Researchers will compare these active drugs to a 'dummy' medicine (placebo) to see if they genuinely improve how well patients recover.

Ultimately, the goal is to help patients have better outcomes after their heart surgery. This means getting out of the intensive care unit sooner, not needing powerful antibiotics or help with breathing, and avoiding severe problems. By understanding if these preventative medicines work, doctors can make better choices to help future heart surgery patients recover more safely and comfortably.

Key takeaways

This study aims to prevent serious virus infections (CMV) after major heart surgery.
It tests if specific antiviral medications improve recovery compared to a dummy treatment.
Participation is for adults having major heart surgery who are at higher risk for CMV complications.
The main goal is to see how many days patients have a good recovery during the first 30 days.
You will be randomly assigned to receive either the active drug or a placebo.

Who may be eligible?

This study is looking for adults aged 18 or older. It's open to both men and women who are having major heart surgery.

You would be considered for the study if you are someone who is generally healthy, but also known to be at a higher risk of developing problems from a common virus called CMV after your operation. The doctors running the study will check if you meet all the specific health requirements to make sure the study is safe and suitable for you.

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 an adult aged 18 or over?
Are you about to have major heart surgery?
Have doctors identified you as being at higher risk for CMV complications after surgery?
Are you generally healthy enough to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the active study medication (Ganciclovir or Valganciclovir, usually as tablets or a liquid) or a placebo (a dummy treatment with no active medicine, given as a liquid). This is done "double-blind," meaning neither you nor your doctor will know which one you are receiving.

The main part of the study involves daily check-ups for 30 days after your surgery to see how you are recovering. Doctors will monitor if you're out of intensive care, if you need certain medications, or if you experience any side effects. There will also be some blood tests to check your immune system and the virus levels, which will happen at the start, at 14 days, and again at 30 days. The total duration of active follow-up for the main goals of the study is 30 days.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that if you receive the active medication, it might help prevent complications from the CMV virus, potentially leading to a smoother and faster recovery after your heart surgery. However, there's also a chance you might receive the placebo. The medicines being tested, like all medicines, can have side effects. Your study doctor will explain all known potential side effects and risks to you in detail. Remember, your participation is completely voluntary, and you have the right 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
Spain

Common questions

What is CMV?

CMV (Cytomegalovirus) is a very common virus that most people have at some point. It usually doesn't cause problems in healthy people, but after major surgery or if your immune system is weak, it can become active and cause illness.

What is 'major heart surgery'?

This refers to significant operations on your heart, like bypass surgery or valve replacement, which are serious procedures that require your body to recover afterwards.

Will I know if I'm getting the real medicine or the dummy one?

No, neither you nor your doctor will know during the study. This is called 'double-blind' and helps ensure the results are fair and unbiased.

How long will I be involved in the study?

The main part of the study will involve daily monitoring for 30 days after your heart surgery, with some blood tests at specific times within that period.

What is a 'good outcome' in this study?

A 'good outcome' means you are alive, out of the intensive care unit, not needing strong antibiotics or breathing support, and haven't had any serious problems related to the study.