Study of childhood high blood pressure and its genetic factors
Natural History Study to Determine Childhood-Onset Essential Hypertension Etiology
This study is trying to find out how genes affect high blood pressure in kids by looking at their health over several years to help create better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2300 (estimated) |
| Ages | 2 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06778239 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include children and adolescents aged 2 years and older with a diagnosis of childhood-onset essential hypertension.
Not a fit: Patients without a history of childhood-onset essential hypertension or those who do not meet the age and blood pressure criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments and management strategies for children suffering from high blood pressure.
How similar studies have performed: While studies on hypertension exist, this specific focus on the genetic aspects of childhood-onset essential hypertension is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.