Study of childhood high blood pressure and its genetic factors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the genetic and molecular processes that contribute to childhood-onset essential hypertension (COEH). Participants aged 2 years and older with a history of COEH will undergo annual clinic visits for up to 10 years, during which they will provide biological samples and undergo physical exams. The study seeks to identify genetic variations associated with COEH and characterize the clinical phenotypes of affected individuals. By understanding these genetic factors, researchers hope to develop more effective treatments for children with high blood pressure.

Why it matters

Who can join: the full rules

* 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 it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Neil A Hanchard, M.D. — National Human Genome Research Institute (NHGRI)
• Study coordinator: Emilyn C Banfield
• Email: COEHstudy@nih.gov
• Phone: (240) 328-0965

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.