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Study on Vericiguat for Children with Heart Failure Due to Left Ventricular Systolic Dysfunction

Fast replyInvestigationalNo 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 heart failure in children and teenagers. Heart failure is a condition where the heart is unable to pump blood effectively. The study is specifically looking at heart failure caused by a problem with the left side of the heart, known as left ventricular systolic dysfunction. The treatment being tested is a medication called Vericiguat, which is taken orally either as a tablet or an oral suspension. Vericiguat is also known by its code name MK-1242.

The purpose of the study is to evaluate how well Vericiguat works in improving heart function in young patients with heart failure. Participants in the study will be randomly assigned to receive either Vericiguat or a placebo. The study will last for several weeks, during which time participants will take the medication and have regular check-ups to monitor their heart health and overall well-being. The study aims to see if Vericiguat can help reduce levels of a specific heart-related protein called NT-proBNP, which is often higher in people with heart failure.

Throughout the study, participants will be closely monitored for any side effects or changes in their condition. The study will also gather information on how the body processes Vericiguat, including how long it stays in the body and how it is cleared. This information will help determine the safety and effectiveness of Vericiguat for treating heart failure in children and teenagers.

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 randomly assigned to receive either the study medication, vericiguat, or a placebo. A placebo is a substance that looks like the medication but does not contain any active ingredients.

    The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are not biased.

  2. Step 2

    Medication administration

    If you are assigned to the vericiguat group, you will take the medication orally in the form of a tablet or oral suspension. The dosage will be either 2.5 mg, 5 mg, or 10 mg, depending on your specific needs and the study protocol.

    The medication will be taken once daily. The exact duration of the medication administration will be determined by the study protocol, but it is expected to last up to 52 weeks.

  3. Step 3

    Regular check-ups

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will include physical examinations, blood tests, and other assessments as needed.

    The main goal is to evaluate the change in a specific blood marker called NT-proBNP from the start of the study to week 16. This marker helps assess heart function.

  4. Step 4

    Monitoring and reporting

    You will be asked to report any side effects or changes in your health during the study. This information is crucial for assessing the safety of the medication.

    The study team will also monitor for any serious events, such as hospitalization due to heart failure or other cardiovascular issues.

  5. Step 5

    Study completion

    At the end of the study period, you will have a final evaluation to assess your overall health and the effects of the treatment.

    The study aims to gather data on the long-term effects of vericiguat, including its safety and how well it works in treating heart failure due to left ventricular systolic dysfunction.

Who can join the trial?

6 criteria

  • Has a history of symptomatic chronic heart failure (HF) due to problems with the heart's left side not pumping well.
  • Has a heart with biventricular physiology, meaning both sides of the heart are working, with a normal left side.
  • Is currently receiving stable medical treatment for heart failure.
  • Has a left ventricular ejection fraction (LVEF) of less than 45%. This is a measure of how well the heart is pumping, checked within 3 months before joining the study.
  • Is of any sex or gender, aged more than 28 days but less than 18 years.
  • If female, is not pregnant or breastfeeding, and meets at least one of the following: not able to have children; uses a highly effective birth control method; has a negative pregnancy test; does not breastfeed during the study and for at least 30 days after; and has had her medical and menstrual history, and recent sexual activity reviewed.

Who cannot join the trial?

3 criteria

  • Patients with a history of **heart failure** due to **systemic left ventricular systolic dysfunction** cannot participate. This means if your heart's left side is not pumping blood well, you are not eligible.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important to check if you fall within the eligible age group.
  • Patients who are part of a vulnerable population, which may include groups like pregnant women or those unable to give consent, are not eligible.
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Investigated drugs

Vericiguat is a medication being studied for its potential to help people with heart failure. Heart failure is a condition where the heart doesn't pump blood as well as it should. Vericiguat works by helping the blood vessels relax and widen, which can make it easier for the heart to pump blood throughout the body. This medication is being tested to see if it can improve heart function and reduce symptoms in children with a specific type of heart failure. The study aims to find out if Vericiguat can lower certain markers in the blood that indicate heart stress, which could mean the heart is working better.

What is already known about the treatment

Vericiguat – Vericiguat is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating heart failure due to systemic left ventricular systolic dysfunction. It is a medication that is still under investigation, and its use is being evaluated in medical research. The main therapeutic indication for vericiguat is to help improve heart function in patients with heart failure. At the molecular level, vericiguat works by stimulating an enzyme called soluble guanylate cyclase, which helps relax blood vessels and improve blood flow, thereby reducing the workload on the heart. It is classified pharmacologically as a soluble guanylate cyclase stimulator.

Investigated diseases

Heart failure due to systemic left ventricular systolic dysfunction – This condition occurs when the left ventricle of the heart is unable to pump blood effectively, leading to a decrease in the amount of blood circulated throughout the body. Over time, the heart muscle may weaken or stiffen, further impairing its ability to function properly. As the condition progresses, individuals may experience symptoms such as shortness of breath, fatigue, and fluid retention. The heart's reduced pumping capacity can lead to congestion in the lungs and other parts of the body. This dysfunction can result from various underlying causes, including coronary artery disease, high blood pressure, or previous heart attacks. The progression of the disease can vary, with some individuals experiencing a gradual worsening of symptoms.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IVTrial ID2022-501238-52-00Protocol codeMK-1242-036Estimated enrolment320 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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