Study of Regadenoson Safety and Pharmacokinetics in Children and Adolescents Needing a Heart Stress MRI

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics and pharmacodynamics the vasodilator drug regadenoson in children who need a specific heart imaging test called pharmacologic stress perfusion cardiac magnetic resonance imaging CMR. The study includes three pediatric age groups adolescents aged 12 to less than 18 years, children aged 2 to less than 12 years, and infants aged 1 to less than 24 months who weigh at least 3 kilograms. Regadenoson is used as the stress agent, and myocardial perfusion imaging MPI serves as a marker to measure the drugs effects and provides a clinical evaluation for the patient. Participants will receive a single intravenous dose of regadenoson adjusted by body weight to approximate the exposure adults receive with a 400 microgram dose. The study is conducted sequentially starting with adolescents, then children, and finally infants, with safety and pharmacokinetic data reviewed by a Data Safety Monitoring Board before progressing to younger groups. The study enrolls at least 54 pediatric patients across multiple centers in Europe, with procedures performed in child-appropriate settings and sedation or general anesthesia used as needed. Resuscitation equipment and trained personnel are available during drug administration. Throughout the study, participants undergo monitoring including physical exams, vital signs heart rate, blood pressure, oxygen saturation, body temperature, blood tests, and 12-lead electrocardiograms before and after regadenoson administration. Blood levels of regadenoson are measured at several time points post-dose. Imaging with dynamic first-pass perfusion MRI and myocardial perfusion reserve analysis occurs about one hour after dosing to assess heart response. Safety data, drug levels, heart responses, and imaging results are recorded to evaluate the drugs effects and tolerability in these pediatric patients.

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