A research study of the diagnostic drug, Regadenoson, in infants, children and young people suffering from heart conditions and diseases

Phase 1

• Conditions: Regadenoson will be used as a pharmacologic stress agent in paediatric patients with cardiovascular problems, undergoing a clinically indicated myocardial perfusion MRI; MedDRA version: 18.1Level: LLTClassification code 10065141Term: Vascular diagnostic procedureSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-000500-26-GB
• Lead Sponsor: Rapidscan Pharma Solutions EU Ltd (RPS EU Ltd)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-30
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patients who are clinically indicated to undergo a diagnostic MPI study using cardiac MRI performed in accordance with the institution’s practice for the paediatric age and condition under evaluation;
2.Male or female, adolescents aged from 12 to <18 years (Part A), children aged from 2 to <12 years (Part B), and infants aged from 1 to <24 months (Part C);
3.Weight >5th percentile and <95th percentile based on age and gender; and a body mass index (BMI) >5th percentile and =90th percentile for age and gender;
4.Acceptable range for BP (systolic / diastolic mmHg):
a.For Parts A and B: 85-130/45-90.
b.For Part C: 80-120/40-80.
5.Acceptable range for pulse:
a.For Part A: 55-100 beats per minute (bpm);
b.For Part B: 60-120 bpm;
c.For Part C: 70-1640 bpm.
6.Restriction of dosing with beta blockers (and preferably other cardioactive medications that may impact the ischaemic reaction to stress, e.g., calcium channel blockers, long-acting nitrates, angiotensin-converting-enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], etc.) in accordance with study site’s routine practice for the stress procedure;
7.Patients and those whose parent(s) or legally authorised representative(s) who, in the Investigator's view, are likely to be compliant and complete the study;
8.Negative urine pregnancy test at screening and at pre-dose on the dosing day for post-menarchal female patients;
9.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 one month before being enrolled in the study and for the duration of the study;
10.Written informed consent and signed age-appropriate paediatric assent (for patients who are able to review and/or read the assent) prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.

Are the trial subjects under 18? yes
Number of subjects for this age range: 54
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Exclusions for the use of gadolinium and MRI are:
a.End stage renal failure (estimated glomerular filtration rate [GFR] <30mL/min/1.73m2);
b.Metallic implant or device (e.g. non-conditional pacemaker);
c.Known allergy to magnetic resonance contrast agents;
2.Exclusion criteria according to the use of general anaesthesia , if being applied;
3.Allergy or intolerance to adenosine, to any component of the regadenoson formulation, or to aminophylline or to its components (ethylenediamine and theophylline);
4.In the judgment of the Investigator, any clinically-significant ongoing medical condition (eg myocardial disease, pericardial inflammatory disease, or severe cardiac outflow obstruction, etc.) that might jeopardise the patient’s safety or interfere with the absorption, distribution, metabolism or excretion of the study drug;
5.Use of any experimental or investigational drug or device within 30 days prior to the first dose of study drug;
6.Patients with 2nd or 3rd degree AV block or sick sinus syndrome with or without an artificial pacemaker, and/or with unstable angina that has not been stabilised with medical therapy and/or with severe hypotension and/or with decompensated states of heart failure;
7.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);
8.Abnormal sitting or semi-recumbent resting BP or pulse (bpm) at screening. If, upon repeat assessment, the sitting or semi-recumbent resting BP or pulse (bpm) at screening is normal, the patient may be evaluated further for inclusion in the study;
9.Dipyridamole use within 48 hours prior to dosing;
10.Consumption of methylxanthine-containing products such as caffeinated coffee, tea, caffeinated soft drinks, cocoa or chocolate in the 12 hours prior to dosing;
11.Aminophylline or theophylline use within 24 hours prior to dosing;
12.History of alcohol abuse or drug addiction, as determined by the Investigator;
13.Currently smokes more than five 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified