RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients

This study is testing a medicine called regadenoson, which helps doctors see how blood flows through the heart during a special heart scan called a stress perfusion CMR. We want to find out if this medicine is safe and works well in children of different ages, from babies (1 month old) to teenagers (up to 18 years old). The children taking part already need this heart scan for their health, for conditions like Kawasaki disease or heart problems they were born with. The study aims to make sure any discomfort for the children is kept to a minimum and that highly trained staff are always available. It's an important step in finding the best ways to diagnose and understand heart conditions in young patients.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

GE Healthcare

Enrolment target

Start

20 May 2021

Estimated completion

01 Dec 2026

Myocardial Ischemia Coronary Artery Disease

What is this study about?

This study is looking at a medicine called regadenoson, which is used during a special type of heart scan called a 'pharmacologic stress perfusion CMR test'. This scan helps doctors see how well blood is flowing through a child's heart, which is important for understanding certain heart conditions like Kawasaki disease or heart problems a child is born with. The medicine makes the heart work a little harder, like during exercise, so doctors can see if there are any areas not getting enough blood.

We need to understand two main things: is regadenoson safe for children of different ages, and how does it act within their bodies? We’re studying babies (from 1 month old), young children (ages 2 to 12), and teenagers (ages 12 to 18) when they need this heart scan. The information we gather will help doctors know the right amount of medicine to use and how to best perform these important scans for young patients.

About 54 children will take part at different hospitals across Europe. Their well-being is our top priority. The study will be done in child-friendly settings by staff who are experts in caring for children. We'll do everything we can to make sure children are comfortable, and if needed, they might receive medicine to help them relax or sleep. There's also a special group of experts called a Data Safety Monitoring Board who will regularly check all the information to make sure the children in the study are safe.

Key takeaways

This study evaluates heart medicine (regadenoson) in children.
It aims to check safety and how the medicine works in young bodies.
Children from 1 month to 18 years old may participate, if they need this specific heart scan.
Highly trained staff and strict safety measures are in place.
Findings could improve heart care for children in the future.
Participation is voluntary and can be stopped at any time.

Who may be eligible?

To join this study, a child must be between 1 month and 18 years old and weigh at least 3 kilograms. They must also already need a special heart scan called a 'pharmacologic stress perfusion CMR test' for a health reason, and their doctor needs to agree that this test is suitable for them. Examples of conditions that might require this scan include Kawasaki disease, heart problems they were born with, or issues after heart surgery or a transplant.

It's important that children on regular medicines have been taking a stable dose for at least 7 days before the study begins. This means no new medicines or changes to existing ones that could affect their heart rate or blood pressure. Parents or guardians must also be able to bring the child for all study appointments. For teenage girls who have started their periods, a pregnancy test will be done, and they must either not be sexually active or be using effective birth control.

Children cannot join if they've had an allergic reaction to certain medicines or MRI dye in the past. Also, if they have any medical devices that are not safe for an MRI scan, or if their doctor thinks the stress perfusion CMR test is not right for them, they won't be able to take part.

Quick self-check

Is your child between 1 month and 18 years old?
Does your child weigh at least 3 kilograms?
Does your child need a special heart scan called a 'stress perfusion CMR test'?
Has your child been taking any regular medicines at a stable dose for the past 7 days?
Has your child ever had an allergic reaction to MRI dye or certain heart medicines?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If a child takes part in this study, they will receive the medicine regadenoson as part of their planned heart scan. This will be a single dose given during the scan. There will be careful monitoring during and after the scan to make sure they are safe and comfortable. The study will aim to minimise discomfort for the patient, and some children may receive sedation or general anaesthetic to help them relax or sleep comfortably during the scan, depending on their age and health needs. There will likely be follow-up appointments to check on their health. The total duration of participation will depend on the monitoring schedule but will largely revolve around the single administration of the study drug and subsequent assessments.

Potential risks and benefits

Participating could help us learn valuable information about treating heart conditions in children, which may benefit future patients. While we always aim for the highest safety, potential risks include possible side effects from regadenoson, such as feeling dizzy or short of breath, or reactions to the MRI contrast dye. There are also standard risks associated with any medical procedure, including the MRI scan itself. Highly trained staff and equipment for emergencies will always be on hand. You and your child have the right to withdraw from the study at any time without affecting their medical care.

Locations (5)

Paris Public Hospitals System; Necker Hospital for Sick Children
Paris, France· Terminated
Mitera Hospital
Athens, Greece· Completed
Bambino Gesu Children Hospital
Roma, Italy· Recruiting
Bristol Royal Hospital for Children
Bristol, United Kingdom· Not yet recruiting
King's College London, Rayne Institute
London, United Kingdom· Recruiting

Common questions

What is regadenoson?

It's a medicine used during heart scans to help doctors see how blood flows through the heart more clearly by making the heart work a little harder.

Why is this study being done in children?

We want to find out if regadenoson is safe and effective for children of different ages, as this information is currently limited, to help improve their heart care.

Will my child be safe in the study?

Yes, patient safety is the highest priority. The study is run by doctors and nurses experienced with children, and there's a special safety board overseeing everything.

Will my child feel pain or discomfort?

Every effort will be made to keep your child comfortable. If needed, medicine to help them relax or sleep (sedation/anaesthetic) can be used during the scan.

What kind of heart scan is involved?

It's a 'pharmacologic stress perfusion CMR test', a special type of MRI scan that shows how blood flows to the heart muscle using the study medicine.

How to find out more

Michelle Straszacker

michelle.straszacker@gehealthcare.com +44 (0) 7827845147 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.