Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Heart Failure due to a specific problem with the heart called Left Ventricular Systolic Dysfunction. This condition affects the heart's ability to pump blood effectively. The study involves a treatment called Vericiguat, which is being tested to see how safe and tolerable it is for children with this type of heart failure. Vericiguat is available in two forms: a tablet and an oral suspension, which is a liquid form that can be swallowed.

The purpose of this study is to monitor the safety and tolerability of Vericiguat, also known by its code name MK-1242. Participants in this study will have previously been part of an earlier study and will continue to receive Vericiguat. The study will observe participants over a period to see if they experience any side effects or need to stop the treatment due to any adverse effects. The study will also look at changes in a specific heart-related protein in the blood, known as N-terminal pro-brain natriuretic peptide (NT-proBNP), which can indicate how well the heart is functioning.

Participants will take Vericiguat by mouth, either as a tablet or a liquid, for a maximum period of 108 weeks. The study aims to ensure that the treatment is safe and well-tolerated by the participants. This trial is an extension of a previous study, allowing researchers to gather more information about the long-term effects of Vericiguat in children with heart failure due to left ventricular systolic dysfunction.

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

    Participation begins after completing the initial study and the follow-up period. Eligibility requires having received at least one dose of the study medication or placebo in the previous study.

    Participants must be able to take medication orally or through a gastric route.

  2. Step 2

    Medication administration

    The medication used in this study is vericiguat, which is administered orally.

    The form of the medication can be a tablet or an oral suspension, depending on the participant's needs.

  3. Step 3

    Monitoring and assessments

    The main objective is to monitor the safety and tolerability of vericiguat.

    Participants will be observed for any adverse events, which are unexpected medical problems that occur during the study.

    The number of participants who discontinue the study due to adverse events will also be recorded.

  4. Step 4

    Secondary assessments

    A secondary assessment involves measuring changes in a specific protein level, known as N-terminal pro-brain natriuretic peptide (NT-proBNP), from the start of the study to week 16.

  5. Step 5

    Study duration

    The study is expected to continue until April 15, 2032.

    Recruitment for the study is estimated to start on July 1, 2024.

Who can join the trial?

4 criteria

  • The patient must have received at least one dose of the study treatment, which could be either the actual medication called vericiguat or a placebo, and must have completed the Week 52 visit and safety follow-up period for the VALOR base study. A placebo is a harmless pill that looks like the real medication but doesn't have any active ingredients.
  • The patient must be able to take medication by mouth or through a tube that goes directly to the stomach.
  • Both men and women can participate in the study.
  • The study includes people who might need extra care or protection, known as a **vulnerable population**. This could include groups like older adults or those with certain health conditions.

Who cannot join the trial?

9 criteria

  • Patients with a history of **allergic reactions** to the study medication or similar drugs. An allergic reaction is when your body reacts badly to something, causing symptoms like rash, itching, or trouble breathing.
  • Patients who are currently taking medications that might **interact** with the study drug. An interaction means the drugs could affect each other, causing unwanted effects or making them less effective.
  • Patients with **severe liver disease**. This means the liver, which helps clean the blood and digest food, is not working well.
  • Patients with **severe kidney disease**. This means the kidneys, which help filter waste from the blood, are not working well.
  • Patients who have had a **heart attack** in the last 3 months. A heart attack happens when blood flow to the heart is blocked, causing damage to the heart muscle.
  • Patients with **uncontrolled high blood pressure**. This means the blood pressure is too high and not being managed well with treatment.
  • Patients who are **pregnant or breastfeeding**. This is to protect the baby, as the effects of the study drug on unborn or nursing babies are not known.
  • Patients who are participating in another clinical trial. This is to ensure the results of this study are not affected by other treatments.
  • Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Vericiguat (MK-1242) is a medication being studied for its safety and tolerability in children with heart failure due to problems with the left side of the heart. It is part of a clinical trial to see how well it works and how safe it is for pediatric patients. Vericiguat helps the heart pump blood more effectively by relaxing blood vessels, which can improve symptoms of heart failure.

What is already known about the treatment

Vericiguat – Vericiguat is administered orally in tablet form and is currently being studied in clinical trials for its safety and tolerability in pediatric patients with heart failure due to systemic left ventricular systolic dysfunction. It is primarily used to treat heart failure, helping to improve heart function. The medication works by stimulating an enzyme called soluble guanylate cyclase, which increases the levels of a molecule that helps relax blood vessels and improve blood flow. Vericiguat is classified 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 that circulates through the body. Over time, the heart muscle may weaken or become stiff, which can further impair its ability to function properly. As the condition progresses, individuals may experience symptoms such as fatigue, shortness of breath, and fluid retention. The heart's reduced pumping capacity can lead to a buildup of fluid in the lungs and other parts of the body. This condition is often associated with other cardiovascular issues, such as high blood pressure or coronary artery disease. Regular monitoring and lifestyle adjustments are typically necessary to manage the symptoms and progression of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506210-40-00Protocol codeMK-1242-043Estimated enrolment254 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.