At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Regadenoson (drug)
- How long the study runs
- Study runs about 67 months (dates as stated)
- About the drug or intervention
- Regadenoson — drug: Regadenoson (Rapiscan®): Single i.v.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by GE Healthcare, is looking at the safety of a medicine called regadenoson in babies, children and teenagers. Regadenoson is used in a heart scan called a cardiac magnetic resonance (CMR) perfusion test, which checks how well blood flows to the heart in conditions such as myocardial ischaemia (reduced blood flow to the heart) and coronary artery disease. The study covers three age groups: infants aged 1 to under 24 months, children aged 2 to under 12 years, and adolescents aged 12 to under 18 years.
Who can take part
- Aged 1 to under 24 months, 2 to under 12 years, or 12 to under 18 years
- Weighs at least 3 kg
- Needs a heart scan called a stress perfusion CMR test, which may be for conditions such as Kawasaki disease, congenital heart disease, congenital coronary abnormalities, or after heart surgery or a transplant
- On a stable dose of all medicines for at least 7 days before the study dose
- In the view of the investigator, likely to follow the study plan and complete it
- Females who have started their periods must have a negative pregnancy test and be abstinent or use effective birth control
Who may not be able to
- Past allergic reaction to regadenoson, gadolinium contrast dye, or aminophylline (or its parts)
- Cannot have an MRI scan, for example due to cochlear implants or implanted cardiac devices
- Kidney problem shown by a low eGFR (a measure of kidney function) below 30 mL/min/1.73 m2 within 24 hours of the scan
- Pregnant or breastfeeding
- Certain ongoing serious medical conditions, such as a recent heart attack, unstable angina, severe heart obstruction or uncontrolled epilepsy, that could put the patient at risk
- Certain heart rhythm problems (2nd or 3rd degree atrioventricular block or sick sinus syndrome without a pacemaker)
- Unstable or actively treated wheezing or bronchospastic lung disease
- Blood pressure or heart rate outside set ranges for their age group
- Taken any experimental drug or device within 30 days before the study dose
- Had caffeine (coffee, tea, soft drinks, cocoa or chocolate) in the 48 hours before the dose, or certain medicines (aminophylline, theophylline or dipyridamole) shortly before
- History of alcohol abuse or drug addiction
- Smokes more than 5 cigarettes a day and cannot stop smoking from midnight before the dose
- Positive urine drug test at screening
What taking part involves
- • A single dose of the study medicine regadenoson during a clinically indicated stress perfusion CMR heart scan
- • The scan and study drug take place on one dosing day
Time commitment: Not stated — ask the trial team about the number of visits and how long taking part lasts.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 4 Weeks to 18 Years
- Who
- All
- Number of participants
- 54
- Started
- 2021-05-20
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for myocardial ischemia
- • Phase1/Phase2 - 54 participants
- • This is a multi-centre, open-label, single-dose safety, tolerability and PK-pharmacodynamics (PD) study of the vasodilator regadenoson in 3 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)
Who can take part?
- • Ages 4 Weeks to 18 Years
- • Diagnosed with myocardial ischemia
Where?
- • Bristol - Bristol Royal Hospital for Children
- • London - King's College London, Rayne Institute
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a multi-centre, open-label, single-dose safety, tolerability and PK-pharmacodynamics (PD) study of the vasodilator regadenoson in 3 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). Regadenoson will be used as the pharmacologic stress agent in this study with MPI serving as both surrogate pharmacodynamic marker of the agent (MPR, MBF) and a clinically evaluable examination for the patient
More detail
This is a multi-centre, open-label, single-dose safety, tolerability and PK-pharmacodynamics (PD) study of the vasodilator regadenoson in 3 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). Regadenoson will be used as the pharmacologic stress agent in this study with MPI serving as both surrogate pharmacodynamic marker of the agent (MPR, MBF) and a clinically evaluable examination for the patient. At least 54 paediatric patients will be enrolled at approximately 10 centres in Europe: at least 24 adolescents aged 12 to \<18 years (Cohort A), at least 18 children aged 2 to \<12 years (Cohort B), and at least 12 infants aged 1 to \<24 months (Cohort C). The study will be conducted in facilities appropriate for children, and by personnel knowledgeable and skilled in working with paediatric patients. Every attempt will be made to minimise the discomfort of the procedures to the patients. General anaesthesia/sedation with no oral-intake instructions may be used in accordance with age / disease specific requirements of the patient and as deemed necessary by the investigator per standard of care / local practice. In addition, adequate resuscitation equipment and personnel trained and certified in advanced life support must be readily available when regadenoson is administered. A Data Safety Monitoring Board (DSMB) will be in place, and will formally review all safety, efficacy, PK and PD information during the conduct of the study to ensure the safety of patients. The study will be performed in a sequential manner across the 3 age groups, by decreasing age from adolescents (Cohort A) to children (Cohort B) and to infants (Cohort C). Dosing recommendations for the paediatric population are based on effective dose levels and PK data in adults. Based on a fixed dose of 400 µg regadenoson administered to adults with a mean body weight of 83.8 kg (body weight range: 42 to 161 kg), the effective mean weight-based dose was 4.8 µg/kg (range: 2.5 to 9.5 µg/kg). Within each age group, dosing will be extrapolated from PK-PD data obtained in adults and will be based on body weight-categories to provide approximately the same exposure as 400 µg in adults. The study will start with Cohort A (adolescents). Before the start of dosing in Cohort B, all safety, PK, and PD data obtained in Cohort A will be reviewed by the DSMB. Before the start of dosing in Cohort C, all safety, PK, and PD data obtained in Cohorts A and B will be reviewed by the DSMB.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 4 Weeks - 18 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a negative urine pregnancy test at screening and at pre-dose on the dosing day
What the study is looking for
- ✓\* Male or female adolescent aged from 12 to \<18 years (Cohort A) or child aged from 2 to \<12 years (Cohort B) or...
- ✓Patient weighs at least 3 kg.
- ✓Patients and those whose parents or legally authorised representatives are, in the Investigator's view, likely to be...
- ✓Post-menarchal female patients must have a negative urine pregnancy test at screening and at pre-dose on the dosing day.
Who cannot take part
- ✗\* Prior allergic reaction to Gd contrast agents and/or regadenoson or any component of its formulation, or to...
- ✗All patients will be screened for eGFR within 24 hours before the exam and patients presenting with eGFR \<30...
- ✗Pregnant or lactating females, or females of childbearing potential not using an acceptable form of birth control...
- ✗Patients with 2nd or 3rd degree atrioventricular block or sick sinus syndrome with or without an artificial pacemaker.
- ✗Out of acceptable range sitting or semi-recumbent resting BP or HR (beats per minute \[bpm\]) at screening as...
See the full criteria
Where Is This Study? (2 UK sites)
Bristol Royal Hospital for Children
Bristol BS28BJ, United Kingdom
King's College London, Rayne Institute
London SE1 7EH, United Kingdom
How to Get in Touch
Michelle Straszacker
Sponsor contactCONTACT
