Effect of High Blood Pressure and Antihypertensive Treatment on Brain Functioning in Children
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      High blood pressure, or hypertension, affects up to 10% of minority children and adolescents.
      Although complications of high blood pressure, such as stroke and heart attack, are uncommon
      in childhood, high blood pressure-related organ damage can occur at a young age. Studies with
      young adults have indicated that high blood pressure can affect the central nervous system,
      resulting in deficits in brain function. However, more research is necessary to confirm the
      association between neurocognitive deficits and high blood pressure in children and to
      determine if these deficits are reversible with treatment. This study will determine whether
      high blood pressure in children and adolescents has subtle effects on learning, attention,
      and concentration. The study will also determine the effect of an antihypertensive treatment
      plan, involving a combination of diet, weight loss, increased exercise, and if needed, blood
      pressure medication, on brain function in children and adolescents receiving treatment for
      high blood pressure.
    

Detailed description: 
      High blood pressure is a condition that normally affects adults, but can affect young
      children and adolescents, as well. High blood pressure in children is most commonly caused by
      unhealthy lifestyle or family history, but it can also be due to disease, such as kidney or
      heart disease. When a person has high blood pressure, the heart must work harder to pump
      blood throughout the body. If left untreated, high blood pressure can eventually cause damage
      to the heart, kidneys, and eyes. Recent studies have linked high blood pressure in children
      to deficits in brain functioning. However, more information is needed to confirm this
      connection and to determine the effectiveness of antihypertensive treatments in restoring
      brain function. This study will determine the effect of high blood pressure on brain
      functioning in children and adolescents. The study will also determine the effect of an
      antihypertensive treatment plan, involving a combination of diet, weight loss, increased
      exercise, and if needed, blood pressure medication, on brain function in children and
      adolescents receiving treatment for high blood pressure.

      Participation in this study will last 12 months and will involve children with high blood
      pressure and children with normal blood pressure. Information on participants' medical
      history and sleep patterns, as well as parent's income and education level, will be
      collected. Participants with suspected high blood pressure will then undergo 24-hour blood
      pressure monitoring using an ambulatory blood pressure cuff. Afterwards, participants who are
      determined to have high blood pressure will undergo an echocardiogram of the heart. These
      participants will soon return to the General Clinical Research Center (GCRC) to undergo
      additional testing, which will include measurements of height, weight, and body mass index; a
      urine sampling; and a blood draw.

      Before beginning potential treatment, both healthy and high blood pressure participants will
      complete a series of thinking and learning tests that will take about 90 minutes. Parents of
      participants will also be asked to answer a 10-minute questionnaire about their child's
      behavior and emotions. Participants with high blood pressure will then start a 12-month
      antihypertensive treatment plan, which will involve a combination of diet, weight loss,
      increased exercise, and if needed, blood pressure medication. A digital blood pressure cuff
      will be provided to participants for at-home blood pressure monitoring. During the treatment
      period, a study nurse will call participants every 1 to 2 weeks for the first 3 months and
      monthly for the remaining 9 months to check on blood pressure readings and to refill
      medications. Participants will be seen at the GCRC once every 3 to 4 months to monitor and
      adjust treatment as needed. Healthy participants will undergo no study treatment during the
      treatment phase.

      Upon completion of the 12 months of treatment, all participants will undergo repeat thinking
      and learning tests, and parents of participants will complete repeat questionnaires.
      Participants with high blood pressure will also repeat the 24-hour blood pressure monitoring
      test.
    

Intervention name(s): High blood pressure treatment
Intervention type(s): Drug
Intervention description(s): Participants who are identified as having high blood pressure will be given by a pediatric nephrologist a 12-month treatment plan for their high blood pressure. The treatment plan will include a combination of diet, weight loss, increased exercise, and if needed, blood pressure medication. Participants receiving medication treatment will be treated with a calcium channel blocker and/or ACE inhibitor.
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurocognitive Function