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Effect of High Blood Pressure and Antihypertensive Treatment on Brain Functioning in Children

2 de junio de 2014 actualizado por: Marc Lande, University of Rochester

Neurocognitive Function in Children With Hypertension

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

100

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New York
      • Rochester, New York, Estados Unidos, 14642
        • University of Rochester, Strong Memorial Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

10 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • English speaking
  • No known learning disorder, disorders of cognitive function, treatment with medications for attention deficit, or history of severe head injury (loss of consciousness for more than 30 minutes)
  • Casual blood pressure greater than or equal to 90th percentile for age, gender, and height during clinic visit and on at least two other previous occasions

Exclusion Criteria:

  • Secondary cause of high blood pressure
  • Chronic disease
  • History of treatment for elevated lead level
  • History of maternal substance use during pregnancy
  • Evidence of obstructive sleep apnea

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
Children with high blood pressure who will receive treatment for high blood pressure
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.
Sin intervención: 2
Children with normal blood pressure who will undergo no treatment

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Neurocognitive function improvement with normalization of blood pressure
Periodo de tiempo: Measured at Month 12
Measured at Month 12

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Treatment of hypertension
Periodo de tiempo: Measured at Month 12
Measured at Month 12
Correlation of neurocognitive deficits with the presence of cardiac hypertrophy, microalbuminuria, and hypertensive retinopathy
Periodo de tiempo: Measured at Month 12
Measured at Month 12
Correlation of the presence of neurocognitive deficits with severity and pattern of hypertension
Periodo de tiempo: Measured at Month 12
Measured at Month 12

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Marc B. Lande, MD, University of Rochester

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2005

Finalización primaria (Actual)

1 de junio de 2009

Finalización del estudio (Actual)

1 de enero de 2010

Fechas de registro del estudio

Enviado por primera vez

13 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

13 de septiembre de 2005

Publicado por primera vez (Estimar)

15 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

4 de junio de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

2 de junio de 2014

Última verificación

1 de junio de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 550
  • K23HL080068 (Subvención/contrato del NIH de EE. UU.)
  • 10361

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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