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RecruitingNCT06778239Updated Sep 3, 2026

Childhood-Onset Essential Hypertension Natural History Study

An observational study in Hypertension and Essential Hypertension, sponsored by National Human Genome Research Institute (NHGRI). Recruiting at 1 site in United States. Open to participants aged 2 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-03.

Primary conditionEssential HypertensionRegistry: HypertensionReclassifiedWhy we changed it
Registry
Hypertension — the first condition term the registry derived for this study.
ClinicalTrials.gg
Essential Hypertension
Why
  1. The study's listed conditions name Essential Hypertension, a narrower term within Hypertension.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Human Genome Research Institute (NHGRI) · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
2,300
Ages
2 Years to 99 Years
Sex
All
01

Study 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....
Read the 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.

02

Conditions studied

  • Hypertension
  • Essential Hypertension

Browse trials for

Keywords

  • Blood Pressure
  • Pediatric
  • childhood hypertension
  • ESSENTIAL HYPERTENSION
  • Hypertension
03

In context

Essential Hypertension Reclassified

478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.

This study's planned enrollment of 2,300 is above the median of 702 across 70 observational studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

National Human Genome Research Institute (NHGRI) is the lead sponsor of 203 studies on the registry; 33 are open to participants now.

Browse National Human Genome Research Institute (NHGRI) studies →

Compared within Essential Hypertension, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypertension. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
2 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study participants will come from hypertension, cardiology, nephrology (kidney), and pediatrician clinics. Participants can also sign themselves up for the study without being referred by their doctor.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

To be eligible to participate in this study, an affected individual must meet one of the following criteria:

  • Age 2-12 years at time of enrollment with a BP of at least >95th percentile or 120/80 mm Hg verified via medical record review and a willingness to provide biological samples, undergo physical exam, provide information related to family and medical history, and undergo imaging/body measurements (e.g., renal ultrasound)
  • Age 13-17 years at time of enrollment with a BP of at least 130/80 mm Hg verified via medical record review and a willingness to provide biological samples, undergo physical exam, provide information related to family and medical history, and undergo imaging/body measurements (e.g., renal ultrasound)
  • Age 18 years or more at time of enrollment with a medical history of meeting the criteria outlined in affected individual inclusion criteria 1 or 2, depending on age at diagnosis (verified via medical record review) and a willingness to provide biological samples, undergo physical exam, and provide information related to family and medical history

To be eligible to participate in this study, an unaffected individual must meet all of the following criteria:

  • First-degree relative to a proband (first identified affected family member) in the study
  • Willingness to provide biological samples, undergo physical exam, and provide information related to family and medical history

To be eligible to participate in this study, an individual with a candidate variant (regardless of known COEH status) must meet all of the following criteria:

  • History of clinical and/or research genomic interrogation
  • Positive genomic interrogation test result for candidate variant identified in earlier stages of study or in prior studies performed by study team
  • Willingness to provide information related to family and medical history, provide access to relevant medical records, undergo physical exam, and undergo imaging/body measurements (if 2-17 years of age and evidence of COEH exists)

Exclusion criteria

EXCLUSION CRITERIA:

An affected individual who meets any of the following criteria will be excluded from participation in this study:

  • >95th percentile
  • Evidence that hypertension is secondary to a known condition (e.g., chronic kidney disease, aortopathy, sleep apnea, etc.)
  • Impaired decision-making capability, with or without a legally-authorized representative

An unaffected individual who meets any of the following criteria will be excluded from participation in this study:

  • Prior or current diagnosis of COEH
  • Second-degree or greater relationship to proband
  • Impaired decision-making capability, with or without a legally-authorized representative

An individual with a candidate variant (regardless of known COEH status) who meets any of the following criteria will be excluded from participation in this study:

  • No prior genomic interrogation findings available for the study team to review to confirm positive candidate variant status
  • Impaired decision-making capability, with or without a legally-authorized representative
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
2,300 participants (estimated)

Groups and cohorts

  • Affected

    Study participants that are 2-17 years old and have COEH or participants that are 18+ years old that were diagnosed with COEH when they were children.

  • Unaffected

    Study participants that are 2+ years old and have never been diagnosed with COEH.

06

What researchers measure

Primary outcomes

  1. Find all genes that cause COEH.

    Time frame: 10 years

Secondary outcomes

  1. Identify all of the ways that COEH affects the body.

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • NIH Clinical Center Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Dec 2034, 114 months after the start.

Of 26 observational studies under Essential Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 52. This study's planned 114 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2025
First posted
Jan 16, 2025
StartActual
May 30, 2025
Primary completionEst.
Dec 9, 2034
CompletionEst.
Dec 9, 2034
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06778239
Lead sponsor
National Human Genome Research Institute (NHGRI)
Responsible party
Sponsor
First posted
Jan 16, 2025
Start date
May 30, 2025
Primary completion
Dec 9, 2034 (estimated)
Completion
Dec 9, 2034 (estimated)
Last update
Sep 3, 2026

Study contacts

Emilyn C Banfield
Contact
COEHstudy@nih.gov
(240) 328-0965
Neil A Hanchard, M.D.
Contact
neil.hanchard@nih.gov
(301) 594-2151
Neil A Hanchard, M.D.
principal investigator · National Human Genome Research Institute (NHGRI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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