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Study on Ganciclovir and Valganciclovir for Preventing Cytomegalovirus in High-Risk Heart Surgery Patients

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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 treatment for patients who have undergone major heart surgery and are at high risk of developing an infection caused by the Cytomegalovirus (CMV). The study involves the use of two antiviral medications: Ganciclovir and Valganciclovir. These medications are designed to help prevent the virus from causing illness in patients who have been in the intensive care unit for three or more days after their heart surgery.

The purpose of the study is to understand how effective these antiviral medications are in preventing CMV infection in patients who are otherwise healthy but have undergone significant heart surgery. Participants in the study will receive either the antiviral medication or a placebo, which is a substance with no active medication. The study will last for a period of 14 days, during which the patients will be monitored closely to assess their response to the treatment.

Throughout the study, various health markers will be measured to evaluate the patients' immune response and the presence of the virus in their blood. The goal is to determine the best approach to prevent CMV infection in this specific group of patients, ultimately improving their recovery and reducing the risk of complications after heart surgery.

The research process

The trial runs in 6 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, written informed consent is required. This ensures understanding and agreement to participate in the trial.

    Eligibility is confirmed based on criteria such as age (18 years or older), recent major heart surgery, and a stay in the intensive care unit for at least 72 hours after surgery.

  2. Step 2

    Screening and initial assessments

    A screening process is conducted to ensure all criteria are met. This includes a negative pregnancy test for women of child-bearing potential.

    Participants must agree to use reliable contraception methods during the treatment period and for a specified time after the last dose of the study medication.

  3. Step 3

    Randomization and treatment initiation

    Participants are randomly assigned to receive either the investigational drug or a placebo. This is a double-blind study, meaning neither the participants nor the researchers know who receives which treatment.

    The investigational drug, valganciclovir, is administered orally. The dosage and frequency are determined by the study protocol.

  4. Step 4

    Treatment period

    The treatment period lasts for 14 days. During this time, participants take the assigned medication as directed.

    Regular monitoring and assessments are conducted to track health status and any side effects.

  5. Step 5

    Follow-up and final assessments

    After the treatment period, participants are monitored for an additional 30 days.

    The primary goal is to assess the number of days with a good outcome, defined as being alive, out of the ICU, and free from severe complications.

  6. Step 6

    End of study

    The study concludes with a final assessment of health and any remaining effects of the treatment.

    Participants may be asked to provide feedback on their experience in the trial.

Who can join the trial?

7 criteria

  • Written informed consent must be obtained before any study-specific assessment is performed. This means you need to agree in writing to participate in the study after being informed about it.
  • Adult patients who are 18 years old or older.
  • Patients who have had a major heart surgery in the last 90 days before joining the study.
  • Patients who stayed in the Intensive Care Unit (ICU) for at least 72 hours after their surgery.
  • Female patients who can have children must have a negative urine pregnancy test at the start and agree to use reliable birth control methods during the study and for one month after the last dose of the study drug.
  • Male patients must use a reliable method of birth control if they are sexually active with a female who can have children, during the study and for three months after the last dose of the study drug.
  • Willingness and ability to follow the study schedule, including visits, treatment plans, lab tests, and other procedures.

Who cannot join the trial?

4 criteria

  • Patients who have not spent at least 3 days in the cardiac surgery intensive care unit (ICU).
  • Patients who do not have a detectable level of **Cytomegalovirus (CMV)** in their blood. **Cytomegalovirus** is a common virus that can infect people and usually does not cause symptoms, but it can be serious in people with weakened immune systems.
  • Patients who are not considered **immunocompetent**. This means their immune system is not functioning normally to fight off infections.
  • Patients who have not undergone major heart surgery.
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Investigated drugs

Antiviral Therapy is a treatment designed to help the body fight off viral infections. In this clinical trial, the antiviral therapy is used to target a specific virus called CMV, which can be a concern for patients who have undergone major heart surgery. The goal of this therapy is to prevent the virus from causing problems in patients who are at high risk due to their time spent in the intensive care unit after surgery. This treatment is given to patients who show signs of the virus in their system, even if they are not showing symptoms yet, to stop the virus from becoming a bigger issue.

What is already known about the treatment

GAN-CAR – This medication is administered as a targeted pre-emptive antiviral therapy, specifically designed for patients undergoing major heart surgery who are at high risk of cytomegalovirus (CMV) infection. Currently, it is being studied in clinical trials to assess its effectiveness in preventing CMV in immunocompetent adults who have spent three or more days in the cardiac surgery ICU. The main therapeutic indication is to prevent CMV infection in these high-risk patients. At the molecular level, the medication works by inhibiting the replication of the CMV virus, thereby reducing the viral load in the body. It is classified pharmacologically as an antiviral agent.

Investigated diseases

Cytomegalovirus Infection – Cytomegalovirus (CMV) infection is caused by a common virus that can infect people of all ages. In healthy individuals, it often remains dormant and causes no symptoms. However, in high-risk situations, such as after major heart surgery, it can become active and lead to complications. The virus can affect various organs and systems, potentially causing inflammation and damage. It is particularly concerning in individuals with weakened immune systems, where it can lead to more severe symptoms. The progression of the infection can vary, with some individuals experiencing mild symptoms while others may develop more significant health issues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501429-19-00Protocol codeFIBHGM-ECNC002-2021Estimated enrolment226 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon

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