HypertensionNCT06778239
Childhood-Onset Essential Hypertension Natural History Study
An observational study of Hypertension and Essential Hypertension, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 99 years
- Conditions the study is for
- Hypertension, Essential Hypertension
- How many people
- 2,300 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2025to 9 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
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- 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)
Who cannot join
- An affected individual who meets any of the following criteria will be excluded from participation in this study:
- BMI >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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Natural History Study to Determine Childhood-Onset Essential Hypertension Etiology
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.
Read more
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.
- Conditions
- Hypertension, Essential Hypertension
- Keywords
- Blood Pressure, Pediatric, childhood hypertension, ESSENTIAL HYPERTENSION, Hypertension
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Find all genes that cause COEH.
Measured: 10 years
Secondary outcomes (1)
Identify all of the ways that COEH affects the body.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start30 May 2025
- Primary completion9 Dec 2034 (estimated)
- Study completion9 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Neil A Hanchard, M.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778239
- Sponsor's protocol ID
- 10001987
- Other IDs
- 001987-HG
- Status last verified
- 1 Sep 2026
- First submitted
- 15 Jan 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History Study to Determine Childhood-Onset Essential Hypertension Etiology
- ClinicalTrials.gov ID
- NCT06778239
- Acronym / sponsor ID
- 10001987
- Conditions
- Hypertension, Essential Hypertension
- Keywords
- Blood Pressure, Pediatric, childhood hypertension, ESSENTIAL HYPERTENSION, Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 30 May 2025 (actual)
- Primary completion
- 9 Dec 2034 (estimated)
- Study completion
- 9 Dec 2034 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (11 listed)
- An affected individual who meets any of the following criteria will be excluded from participation in this study:
- BMI >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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Find all genes that cause COEH.
Time frame: 10 years
1 secondary outcome
Identify all of the ways that COEH affects the body.
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neil A Hanchard, M.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Essential Hypertension, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilyn C Banfield ((240) 328-0965, COEHstudy@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Find all genes that cause COEH. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.