Study of Regadenoson in Paediatric Patients
Research type
Research Study
Full title
An Open-label, Single-dose, Safety and Pharmacokinetic Study of Regadenoson in Paediatric Patients.
IRAS ID
271067
Contact name
Michelle Straszacker
Contact email
Sponsor organisation
GE Healthcare Ltd.
Eudract number
2019-002615-25
Duration of Study in the UK
4 years, 2 months, 1 days
Research summary
Stress testing, which can be done in different ways, such as through exercise tests, is used in medicine as a way to try and confirm whether or not a person has significant damage in disease in their heart's major blood vessels.
However, adolescents and children sometimes have difficulty performing some of the available stress tests involving exercise; these age groups may be able to have stress testing where a medicine is given to mimic the effect of exercise on the heart, followed by a cardiac Magnetic Resonance Imaging (MRI) scan.
The purpose of this study is to investigate if the drug, Regadenoson (Rapiscan®), which has been proven safe in adults, is also safe for use in younger patients, when carrying out a cardiac MRI scan. The study will help to learn more about how the study drug moves into, through and out of the body and more about the effects of the study drug on the heart rate when performing stress testing in adolescents and children.
The study will be carried out in three paediatric age groups, for whom a pharmacologic stress perfusion CMR test is clinically indicated: adolescents aged 12 to <18 years (Cohort A), children aged 2 to <12 years (Cohort B), and infants aged 1 to <24 months and who weigh at least 3 kg (Cohort C).
The study consists of up to three study visits (including 1 follow-up visit) and 2 follow-up telephone calls. A number of assessments and procedures may be performed during the study including physical examinations, blood sample tests, heart function assessment (electrocardiograms) and cardiac MRI scan.
At least 54 paediatric patients will be enrolled at approximately 10 centres in Europe and participation in the study is expected to last for up to 6 months.
The Study is sponsored by GE Healthcare Ltd.REC name
London - Central Research Ethics Committee
REC reference
20/LO/0116
Date of REC Opinion
27 Mar 2020
REC opinion
Further Information Favourable Opinion