Pediatric Hypertension Feasibility Assessment

Study type
Feasibility Study
Date of Approval
Study reference ID
FS_004489
Lay Summary

Over 8 million people in the UK are affected by high blood pressure. While there are several treatments available today the majority of studies for these products were done on adults or patients >55 years of age. Since this condition is not as common in children and adolescents the available medications are fewer and not well studies or testing in this specific demographic. However we expect the number of children with high blood pressure to increase in the future and as such we want to learn about this population and understand the effects of current and possibly future treatments for high blood pressure in children and adolescents. The aim of our study is to better understand how many children in the UK currently suffer from high blood pressure to help inform future interventions that can address this condition in children which is not currently well studied.

Technical Summary

The aim of our study is to determine the prevalence of is pediatric uncontrolled/resistant hypertension, pediatric hypertension population refractory to a single anti-hypertensive agent, and primary hyperaldosteronism subpopulation.. This will help understand the full patient population that could potentially benefit from any upcoming interventions and policies that address the management of pediatric hypertension and pediatric aldosteronism in the UK.

Uncontrolled Hypertension definition = stable regimen of ≥ 2 anti-HTN meds, from different therapeutic classes (at least one must be a diuretic) max tolerated dose for at least 4 wks prior to Screening

Resistant Hypertension definition = stable regimen of ≥ 3 anti-HTN meds, from different therapeutic classes (at least one must be a diuretic), at max tolerated dose for at least 4 wks prior to Screening

Prevalence of hypertensive etiologies by age – timeframe (1 year and 3 year)​
1. < 6 years
2. > 6 years -

Health Outcomes to be Measured

eGFR, Blood Pressure, HbA1c, serum aldosterone

Collaborators

Jay Were - Chief Investigator - Parexel International Limited (UK)
Nathan Lee - Corresponding Applicant - Parexel International LLC (USA)
Mateo Delclaux Rodriguez-Rey - Collaborator - Parexel International Limited (UK)