Phase 2 Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The patient is an adolescent aged 12 to under 18 years (Cohort A), a child aged 2 to under 12 years (Cohort B), or an infant aged 1 to under 24 months (Cohort C)
• The patient weighs at least 3 kg
• The patient has been assessed by the investigator as needing, and being medically suitable for, a drug-assisted stress heart imaging scan (called a pharmacologic stress perfusion CMR), for further evaluation of a heart condition — such as Kawasaki disease, a congenital heart condition, an abnormality of the coronary arteries, or a condition following heart surgery or transplant
• The patient's medications have remained unchanged (no additions, removals, or dose changes) for at least 7 days before the study dose — specifically medications that could affect heart rate or blood pressure
• Both the patient and their parent or legally authorised representative are, in the investigator's view, likely to follow the study requirements and complete the study
• Female patients who have started their menstrual periods must have a negative urine pregnancy test at the screening visit and again on the day of dosing
• Female patients who have started their menstrual periods must have been using an effective form of contraception (such as an intrauterine device, oral contraceptives, implants, injections, diaphragm with spermicide, cervical cap, or their partner using a condom) for at least 30 days before enrolling, or must be abstaining from sexual activity

Who may not be able to join:

• People who have previously had an allergic reaction to gadolinium-based contrast dye, or to the study drug regadenoson or any of its ingredients, or to aminophylline or its components (ethylenediamine and theophylline)
• People for whom an MRI scan is not medically appropriate based on the institution's guidelines — including those with cochlear implants or implanted heart devices — or who the investigator considers unsuitable for a drug-assisted stress heart scan
• People whose kidney function test (eGFR, measured within 24 hours before the scan) falls below a certain level (below 30 mL/min/1.73 m², calculated using the Schwartz formula)
• Females who are pregnant or breastfeeding, or females of childbearing potential who are not using an acceptable form of contraception (a negative urine pregnancy test is also required)
• People who, in the investigator's judgement, have a significant ongoing medical condition that could put them at risk — such as a recent heart attack, unstable chest pain within the past 5 days, inflammation around the heart, severe blockage of blood flow out of the heart, acutely worsening heart failure, uncontrolled epilepsy, or a high risk of seizures — or who have significant abnormal laboratory results
• People with second- or third-degree heart block, or sick sinus syndrome (a condition affecting the heart's natural pacemaker), whether or not they have an artificial pacemaker
• People with known or suspected airway-narrowing or bronchospastic lung disease that is unstable or requires active treatment — for example, wheezing on examination, frequent flare-ups, or current use of a bronchodilator or corticosteroids
• People whose blood pressure or heart rate at rest falls outside the acceptable ranges for their age group at the screening visit (confirm with trial site for the exact ranges that apply to a specific age)
• People who have taken part in another clinical trial or used an experimental drug or device within the 30 days before the study dose
• People who have consumed caffeine-containing products — such as coffee, tea, caffeinated soft drinks, cocoa, or chocolate — in the 48 hours before the study dose
• People who have used aminophylline or theophylline within 24 hours, or dipyridamole within 48 hours, before the study dose
• People with a history of alcohol abuse or drug addiction, as determined by the investigator
• People who currently smoke more than 5 cigarettes (or the equivalent) per day and would not be able to stop smoking from midnight before the dosing day until the end of the study
• People who have a positive urine drug screen at the screening visit (testing for amphetamines, barbiturates, cannabinoids, cocaine, ethanol, and opiates) — this applies to all patients in Cohort A, and to younger patients where the investigator considers it age-appropriate; people taking prescribed medications containing these substances may be reconsidered only if the investigator and medical monitor agree it is appropriate

Important: Always verify eligibility with the trial site directly before applying.