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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Katholieke Universiteit te Leuven	Leuven	Belgium
Medizinische Hochschule Hannover	Hanover	Germany
Unidade Local De Saude De Lisboa Ocidental E.P.E.	Carnaxide	Portugal
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
ASST Fatebenefratelli Sacco	Milan	Italy
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Assistance Publique Hopitaux De Paris	Paris	France
KBC Zagreb	Zagreb	Croatia
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Tampere University Hospital	Tampere	Finland
Karolinska University Hospital	Solna	Sweden
Assistance Publique Hopitaux De Paris	Paris	France
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Rigshospitalet	Copenhagen	Denmark
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Deutsches Herzzentrum Berlin	Berlin	Germany
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Gottsegen National Cardiovascular Center	Budapest	Hungary
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Children’s Health Ireland	Dublin	Ireland
Apywscyxhc Pasvqstt Hfybjdnl Dp Mkklxffpm	Marseille	France
Eszmlus Uxoawzopqjst Mfcdlwh Ctbnbqy Rrbrlsjtx (wsmnvqt Mje	Rotterdam	The Netherlands
Aipcgiy Opdqfozluyi Uqrhsulbbjutm Cpjpaqmyqxqo Djhhb Srlogo E Dufuf Sjnxamv Dg Tljoyh	Turin	Italy
Ucozctzcxktppf Cqauhju Kqujcrdsm	Gdansk	Poland
Anuojzf Orkmljrkdgj Pypu Gflbxhbn Xnljq	Bergamo	Italy
Uouwqdsxyipr Mnemueo Cknmxxr Ghfddzkev	Groningen	The Netherlands
Fgiuyorqy Pdga Lt Iobemudozmcqr Bwrughyui Dyn Hnsyvxfj Ughqvleuebcth Ly Prd	Madrid	Spain
Haofwxqx Vdlx ddflrask	Barcelona	Spain
Hzwqusva Ufmlvfamvwuon dc A Cfjmoo	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	15.02.2023
Croatia	Recruiting	15.02.2023
Denmark	Recruiting	15.02.2023
Finland	Recruiting	15.02.2023
France	Not recruiting	15.02.2023
Germany	Recruiting	15.02.2023
Hungary	Recruiting	15.02.2023
Ireland	Recruiting	15.02.2023
Italy	Recruiting	15.02.2023
Poland	Not recruiting	15.02.2023
Portugal	Recruiting	15.02.2023
Spain	Recruiting	15.02.2023
Sweden	Recruiting	15.02.2023
The Netherlands	Recruiting	15.02.2023

Trial locations

Investigated drugs:

Vericiguat

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.

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 ID:

2022-501238-52-00

Protocol code:

MK-1242-036

NCT ID:

NCT05714085

Trial Phase:

Therapeutic use (Phase IV)

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

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