Childhood-Onset Essential Hypertension Natural History Study

Recruiting

• Conditions: Hypertension; Essential Hypertension

• Registration Number: NCT06778239
• Lead Sponsor: National Human Genome Research Institute (NHGRI)

Brief Summary

Background:

Childhood-onset essential hypertension (COEH) is high blood pressure that develops in children and teens. High blood pressure is a major risk factor for heart disease. COEH is more likely to be caused by changes in genes rather than by factors like stress or diet. Researchers want to learn more about how changes in genes relate to COEH. They hope to use that information to develop better treatments for children with high blood pressure.

Objective:

This natural history study will look for genes and gene changes that may lead to COEH.

Eligibility:

People aged 2 years and older with COEH or who had COEH when they were children. Healthy relatives of those with COEH are also needed.

Design:

Participants will have one clinic visit per year for up to 10 years. All participants will have a physical exam. They will provide samples of blood and urine. At their first visit, they will have a swab (like a Q-tip) rubbed between their gums and cheeks. They may agree to having a skin biopsy; a piece of skin about the size of a pencil eraser will be removed.

Affected participants aged 2 to 17 years old will have additional tests:

* They will have sensors placed on their skin to look at their blood vessels and see how blood is moving in their bodies.

* They will lie or stand while a machine measures the amount of fat and muscle in their bodies.

* They will have an ultrasound; a wand will be rubbed against their skin to take pictures of their kidneys.

Other things are optional for all participants:

* They may have photographs taken of their bodies.

* They may have tests of their heart function.

* They may have different types of imaging scans.

Detailed Description

Study Description:

This study seeks to identify molecular processes and genetics that contribute to the development of childhood-onset essential hypertension (COEH) in a diverse cohort of children. Identification of blood pressure (BP)-regulating pathway(s) involved in COEH will allow for targeted and individualized therapy.

Objectives:

Primary Objective:

Elucidate the molecular genetic processes associated with developing COEH.

Secondary Objective:

Characterize the vascular, clinical, and laboratory phenotypes seen in patients with COEH.

Endpoints:

Primary Endpoint:

Evidence that saturation of the allelic spectrum for COEH has been reached.

Secondary Endpoint:

Completion of exhaustive phenotyping on COEH patients.

Study Timeline

• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-16
• Status Verified: 2025-05-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-28
• Study Start: 2025-06-02
• Primary Completion: 2034-12-09
• Study Completion: 2034-12-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Find all genes that cause COEH.	10 years

Secondary Outcome Measures

Name	Time	Method
Identify all of the ways that COEH affects the body.	10 years

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States