NCT06778239 · National Human Genome Research Institute (NHGRI)
Childhood-Onset Essential Hypertension Natural History Study
What this study is about
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.
View original scientific description
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....
Primary outcome measures
Find all genes that cause COEH.
Time frame: 10 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- 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
Where
- Bethesda, Maryland
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 27, 2026 · Source of record for eligibility and locations