RECRUITING

Childhood-Onset Essential Hypertension Natural History Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Natural History Study to Determine Childhood-Onset Essential Hypertension Etiology

Quick Facts

Study Start:2025-01-21
Study Completion:2034-12-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06778239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * 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)
  3. * 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
  4. * First-degree relative to a proband (first identified affected family member) in the study
  5. * Willingness to provide biological samples, undergo physical exam, and provide information related to family and medical history
  6. * History of clinical and/or research genomic interrogation
  7. * Positive genomic interrogation test result for candidate variant identified in earlier stages of study or in prior studies performed by study team
  8. * 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)
  1. * BMI \>95th percentile
  2. * Evidence that hypertension is secondary to a known condition (e.g., chronic kidney disease, aortopathy, sleep apnea, etc.)
  3. * Impaired decision-making capability, with or without a legally-authorized representative
  4. * Prior or current diagnosis of COEH
  5. * Second-degree or greater relationship to proband
  6. * Impaired decision-making capability, with or without a legally-authorized representative
  7. * No prior genomic interrogation findings available for the study team to review to confirm positive candidate variant status
  8. * Impaired decision-making capability, with or without a legally-authorized representative

Contacts and Locations

Study Contact

Neil A Hanchard, M.D.
CONTACT
(301) 594-2151
COEHstudy@nih.gov

Principal Investigator

Neil A Hanchard, M.D.
PRINCIPAL_INVESTIGATOR
National Human Genome Research Institute (NHGRI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Human Genome Research Institute (NHGRI)

  • Neil A Hanchard, M.D., PRINCIPAL_INVESTIGATOR, National Human Genome Research Institute (NHGRI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-21
Study Completion Date2034-12-09

Study Record Updates

Study Start Date2025-01-21
Study Completion Date2034-12-09

Terms related to this study

Keywords Provided by Researchers

  • Blood Pressure
  • Pediatric
  • childhood hypertension
  • ESSENTIAL HYPERTENSION
  • Hypertension

Additional Relevant MeSH Terms

  • Hypertension
  • Essential Hypertension