NCT06778239Recruiting
Childhood-Onset Essential Hypertension Natural History Study
Natural History Study to Determine Childhood-Onset Essential Hypertension Etiology
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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....
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2300 (estimated)
- First submitted
- 15 Jan 2025
- Start date
- 30 May 2025
- Primary completion date
- 9 Dec 2034
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Diseases
- High blood pressure
- NCT number
- NCT06778239
What you commit to
- Study type: Observational
- Planned participants: 2300
- From 30 May 2025 to the primary completion date, 9 Dec 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or current diagnosis of COEH
- No prior genomic interrogation findings available for the study team to review to confirm positive candidate variant status
Other illness
- Evidence that hypertension is secondary to a known condition (e.g., chronic kidney disease, aortopathy, sleep apnea, etc.)
Other
- An affected individual who meets any of the following criteria will be excluded from participation in this study:
- BMI \>95th percentile
- 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:
- 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:
- Impaired decision-making capability, with or without a legally-authorized representative
Criteria the registry did not label
- 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)
Age in the registry: 2 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.