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

3 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Gottsegen National Cardiovascular Center Budapest Hungary
Azienda Ospedaliera di Padova Padua Italy
Universitaetsklinikum Erlangen AöR Erlangen Germany
Region Skane Skanes Universitetssjukhus Lund Sweden
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Robert Debre University Hospital Paris France
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Rigshospitalet Copenhagen Denmark
Pirkanmaan hyvinvointialue Tampere Finland
Children’s Health Ireland Dublin Ireland
Uapdhnxqkruo Mcqwvef Cijivst Gtdvgsveb Groningen The Netherlands
Alcsuflymt Pxhgumka Hsbdttik Dh Miovbderz Marseille France
Ucexeqqnxoippe Cwzajsf Kwkbapziv Gdansk Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.07.2024
Denmark Denmark
Not recruiting
01.07.2024
Finland Finland
Not recruiting
01.07.2024
France France
Not recruiting
01.07.2024
Germany Germany
Not recruiting
01.07.2024
Hungary Hungary
Not recruiting
01.07.2024
Ireland Ireland
Not recruiting
01.07.2024
Italy Italy
Not recruiting
01.07.2024
Poland Poland
Not recruiting
01.07.2024
Portugal Portugal
Not recruiting
01.07.2024
Spain Spain
Not recruiting
01.07.2024
Sweden Sweden
Not recruiting
01.07.2024
The Netherlands The Netherlands
Not recruiting
01.07.2024

Trial locations

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.

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 ID:
2023-506210-40-00
Protocol code:
MK-1242-043
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A Study Testing Drug Combination for Heart Failure in Women Comparing Increased Doses to Standard Care

    Recruiting

    3 1 1 1
    Italy
  • Study of PF-07328948 tablets compared to placebo in adults with heart failure to evaluate effects on symptoms and physical function

    Recruiting

    2 1
    Investigated diseases:
    Bulgaria Czechia France Hungary Poland Spain