Study identification

EU PAS number

EUPAS1000000714

Study ID

1000000714

Official title and acronym

DARWIN EU® - RR Childhood hypertension and sartans prescribing in children

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Finland
France
Germany
Hungary
Netherlands
Norway
Spain

Study description

Childhood hypertension (CHT), defined as elevated blood pressure in children and adolescents, is a significant health concern due to its association with organ damage during childhood, increased risk of hypertension as a young adult, and serious adverse cardiovascular outcomes in adulthood. CHT can be classified into two main categories. Primary hypertension refers to cases without an identifiable underlying cause, while hypertension that results from a specific underlying, potentially reversible cause, is classified as secondary hypertension. Secondary hypertension is frequently caused by coarctation of the aorta or renal diseases but can also be triggered by other causes.(4) Among the pharmacological options available for managing CHT, angiotensin receptor blockers, commonly referred to as sartans, are among the recommend first-line antihypertensive treatments. However, real-world data on prevalence of CHT and the prescribing patterns of sartans, and other antihypertensive medications in the paediatric populations remain limited. This study aims to generate real-world evidence on the epidemiology of CHT and prescribing patterns of sartans, and other antihypertensive medication among individuals with CHT across Europe to support regulatory decision-making and inform clinical practice.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Ellen Gerritsen

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable