Recruiting

Testing a heart stress medication in children and infants

Plain-English translation of NCT04604782 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This study is testing a medication called in children and infants to see if it is safe and how their bodies handle it. is used to stress the heart during a special imaging test (called a CMR scan) that helps doctors see how well blood is flowing to the heart. Right now, this medication is used in adults, but doctors need to learn if it works safely in younger patients.

Children and infants sometimes need special heart imaging tests to check for heart problems, but the medication used to stress the heart during these tests hasn't been properly studied in young patients. This trial will help doctors understand the right dose and safety profile of this medication for children of different ages.

Do you qualify?

You likely qualify if…

you are between 1 month and 18 years old (the study includes three age groups: infants 1–24 months, children 2–12 years, and adolescents 12–18 years)
you weigh at least 3 kilograms (about 6.5 pounds)
your doctor has determined that you clinically need a heart imaging scan (such as for evaluation of congenital heart disease, Kawasaki disease, or after heart surgery)
you have been on the same heart medications for at least 7 days before the study with no changes to doses
if you are a post-menarchal girl, you have a negative pregnancy test and are using effective birth control

You likely don't qualify if…

you have ever had an allergic reaction to regadenoson, gadolinium contrast dye, aminophylline, or related medicines
you have certain heart conditions that your doctor says make a stress test unsafe (such as a heart attack in the last 5 days, severe heart valve obstruction, or unstable heart failure)
you have certain types of irregular heartbeats (2nd or 3rd degree heart block or sick sinus syndrome)
you have kidney function that is too low (measured by eGFR)
you have unstable lung disease like asthma that is not well controlled, or you are pregnant or breastfeeding

What participation looks like

Your child will visit one of about 10 study centers in Europe for a single visit. During this visit, the medication will be given once while your child's heart is being monitored, and a heart imaging scan (CMR) will be performed to see how the medication affects blood flow to the heart. Depending on your child's age, sedation or general anesthesia may be used to keep them comfortable during the scan. The study team will monitor your child closely during and after the procedure to make sure the medication is safe.

AI-generated summary from trial data · Jun 2, 2026 · Not medical advice

Trial locations(5 sites)

France

Paris Public Hospitals System; Necker Hospital for Sick Children, Paris

Greece

Mitera Hospital, Athens

Italy

Bambino Gesu Children Hospital, Roma

United Kingdom

Bristol Royal Hospital for Children, Bristol

King's College London, Rayne Institute, London