Study on the Safety and Effects of Regadenoson and Gadobutrol in Heart Imaging for Children with Cardiovascular Conditions

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What is this study about?

This clinical trial is focused on studying the safety and effects of a medication called Regadenoson in children who need a special type of heart scan. This scan, known as radionuclide myocardial perfusion imaging, helps doctors see how well blood is flowing to the heart muscle. The study involves children aged from 1 month to 18 years who may have heart conditions such as Kawasaki disease, congenital heart diseases, or have had heart surgery or a transplant.

The purpose of the study is to understand how safe and tolerable a single dose of Regadenoson is when given through an injection into a vein. The study will also look at how the medication affects heart rate in different age groups: infants, children, and adolescents. Another medication, Gadovist, which is a type of contrast used in imaging tests, may also be used during the study.

Participants will receive a single dose of Regadenoson adjusted to their body weight. The study will monitor any side effects, changes in vital signs like blood pressure and heart rate, and other health indicators. The relationship between the medication and changes in heart rate will be assessed, considering factors like age, gender, and body weight. The study aims to provide valuable information on the use of Regadenoson in young patients undergoing heart scans.

1 joining the study

Upon joining the study, the patient is assessed to ensure they meet the inclusion criteria. This includes being within the specified age range and weight, needing a specific heart test, and having a stable medication regimen for at least 7 days prior to the study.

2 preparation for the test

Before the test, the patient undergoes a physical examination and various tests to establish baseline health metrics. These include checking vital signs such as blood pressure, heart rate, oxygen levels, and body temperature, as well as conducting an ECG and laboratory tests.

3 administration of regadenoson

The patient receives a single dose of regadenoson through an intravenous injection. The dose is adjusted based on the patient’s body weight. This medication is used to help visualize blood flow in the heart muscle during the imaging test.

4 imaging test

Following the administration of regadenoson, the patient undergoes a heart imaging test called pharmacologic stress perfusion CMR. This test helps evaluate blood flow in the heart muscle and is used for further assessment of cardiovascular conditions.

5 monitoring and follow-up

After the test, the patient is monitored for any side effects or changes in health status. This includes observing for any adverse events, changes in vital signs, and conducting follow-up tests as necessary.

6 completion of the study

The study concludes with a final assessment of the patient’s health and the collection of data regarding the safety and effects of regadenoson. The study aims to understand the medication’s impact on heart rate and other health parameters.

Who Can Join the Study?

The patient must be a male or female adolescent aged from 12 to less than 18 years, a child aged from 2 to less than 12 years, or an infant aged from 1 to less than 24 months.
The patient must weigh at least 3 kilograms.
The patient needs to have a pharmacologic stress perfusion CMR test. This is a special heart test that uses medicine to help see how well blood flows through the heart.
The patient must be on a stable medication regimen for at least 7 days before the study. This means no changes in their medicines that could affect their heart rate or blood pressure.
The patient and their parents or guardians must be likely to follow the study rules and complete the study.
For female patients who have started menstruating, they must have a negative urine pregnancy test at the start and before the study dose is given.
For female patients who have started menstruating, they must be practicing abstinence or using an effective form of birth control for at least 30 days before joining the study.
The parents or legally authorized representatives must sign an Informed Consent Form. This form shows they understand the study and agree for the patient to participate. If the patient is old enough, they must also sign a form agreeing to take part.

Who Cannot Join the Study?

Where you can join this trial?

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Other Sites

Site Name	City	Country
Mitera S.A.	Athens	Greece
Hopital Beaujon	Clichy	France
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Acauoyh Oywkuqmmllx Pcbr Grlwhobf Xhlzd	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
France	Recruiting	31.03.2020
Greece	Recruiting	31.03.2020
Italy	Recruiting	31.03.2020

Trial locations

Investigated drugs:

Regadenoson is a medication used in this clinical trial to study its safety and how it behaves in the body when given as a single dose. It is administered through an intravenous injection, which means it is given directly into a vein. The trial focuses on pediatric patients, meaning children and infants, to see how their bodies handle the medication and to observe any effects it might have on their heart rate. The study aims to ensure that the medication is safe and well-tolerated in young patients.

Kawasaki Disease – This is an illness that primarily affects children and causes inflammation in the walls of some blood vessels in the body. It often leads to

Trial ID:

2024-515244-22-00

Protocol code:

GE-262-001

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of Regadenoson and Gadobutrol in Heart Imaging for Children with Cardiovascular Conditions

What is this study about?

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