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Looking for participantsPhase1/Phase2

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

Sponsor: GE Healthcare

NCT ID: NCT04604782

View on ClinicalTrials.gov ↗

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.

Myocardial IschemiaCoronary Artery Disease

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What we know so far

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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

have a negativeeGFRwith a positive

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
Inclusion Criteria: * \* Male or female adolescent aged from 12 to \<18 years (Cohort A) or child aged from 2 to \<12 years (Cohort B) or infant aged from 1 to \<24 months (Cohort C). * Patient weighs at least 3 kg. * Patients who need to undergo a clinically indicated pharmacologic stress perfusion CMR test and who are considered fit for a pharmacological stress perfusion CMR by the investigator. The pharmacologic stress perfusion CMR may be performed in patients for further evaluation of cardiovascular conditions or diseases, such as, but not limited to, Kawasaki disease, congenital heart diseases, congenital coronary abnormalities, and post-cardiac surgery / transplantation, etc. * Stable medication regimen for at least 7 days prior to dosing. Stable is defined as no addition, discontinuation, or change of any medications (or their doses), that could alter the rate-pressure product (HR x BP). * Patients and those whose parents or legally authorised representatives are, in the Investigator's view, likely to be compliant and complete the study will be eligible to participate * Post-menarchal female patients must have a negative urine pregnancy test at screening and at pre-dose on the dosing day. * Post-menarchal female patients must be practicing abstinence, or be using an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 30 days before being enrolled in the study Exclusion Criteria: * \* Prior allergic reaction to Gd contrast agents and/or regadenoson or any component of its formulation, or to aminophylline or to its components (ethylenediamine and theophylline). * Standard clinical contraindications to MRI as per institutional guidance, including patients with cochlear implants and implanted cardiac devices, or considered unfit for a pharmacologic stress perfusion CMR test by the investigator. * All patients will be screened for eGFR within 24 hours before the exam and patients presenting with eGFR \<30 mL/min/1.73 m2 (by the Schwartz formula) will be excluded. * Pregnant or lactating females, or females of childbearing potential not using an acceptable form of birth control (negative urine pregnancy test also required). * In the judgment of the Investigator, any clinically significant ongoing medical condition (e.g., myocardial infarction, or unstable angina within 5 days, pericardial inflammatory disease, severe cardiac outflow tract obstruction, acutely decompensated heart failure, uncontrolled epilepsy, high risk for seizures, etc.) or clinically significant laboratory abnormality that is considered to potentially jeopardise the patient's safety. * Patients with 2nd or 3rd degree atrioventricular block or sick sinus syndrome with or without an artificial pacemaker. * Known or suspected bronchoconstrictive and bronchospastic lung disease either being unstable or requiring active treatment (e.g., wheezing noted on physical exam, frequent exacerbations or active treatment with a bronchodilator or corticosteroids). * Out of acceptable range sitting or semi-recumbent resting BP or HR (beats per minute \[bpm\]) at screening as provided below: 1. Acceptable range for BP (systolic / diastolic mmHg): * For Cohorts A and B: 85-130 / 45-90 * For Cohort C: 80-120 / 40-80 b) Acceptable range for HR: * For Cohort A: 55 to 100 bpm * For Cohort B: 60 to 120 bpm * For Cohort C: 70 to 160 bpm * Use of any experimental or investigational drug or device within 30 days prior to dosing with study drug * Consumption of methylxanthine-containing products such as caffeinated coffee, tea, caffeinated soft drinks, cocoa or chocolate in the 48 hours prior to dosing * Aminophylline or theophylline use within 24 hours, dipyridamole use within 48 hours prior to dosing. * History of alcohol abuse or drug addiction, as determined by the Investigator * Currently smokes more than 5 cigarettes or equivalent per day, and if eligible for the study, would not be able to abstain from smoking from midnight prior to dosing until the end of the study period * Positive urine drug screen at the screening visit, including amphetamines, barbiturates, cannabinoids, cocaine, ethanol and opiates. This will be performed for all patients in Cohort A and those patients at age-appropriate risk in Cohorts B and C, as determined by the investigator. Note: If the patient is currently receiving prescribed medications containing any of these ingredients, re-screening can only be considered if found acceptable based on the best medical judgement of the investigator and after discussion with the medical monitor. Otherwise, patients with a positive urine drug test will be considered a screen failure.

Where Is This Study? (2 UK sites)

Bristol Royal Hospital for Children

Bristol BS28BJ, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

King's College London, Rayne Institute

London SE1 7EH, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Michelle Straszacker

Sponsor contact

CONTACT

+44 (0) 7827845147 michelle.straszacker@gehealthcare.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04