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

NCT00178490 | Completed Phase 1

• 3 other identifiers: 550K23HL08006810361
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Neurocognitive Function

Outcome Measures

Primary Outcomes (1)

• Neurocognitive function improvement with normalization of blood pressure

  Measured at Month 12

Secondary Outcomes (3)

• Treatment of hypertension

  Measured at Month 12

• Correlation of neurocognitive deficits with the presence of cardiac hypertrophy, microalbuminuria, and hypertensive retinopathy

  Measured at Month 12

• Correlation of the presence of neurocognitive deficits with severity and pattern of hypertension

  Measured at Month 12

Study Arms (2)

1

EXPERIMENTAL

Children with high blood pressure who will receive treatment for high blood pressure

Drug: High blood pressure treatment

2

NO INTERVENTION

Children with normal blood pressure who will undergo no treatment

Interventions

High blood pressure treatment DRUG

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.

1

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Rochester, Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

Related Publications (2)

• Lande MB, Kaczorowski JM, Auinger P, Schwartz GJ, Weitzman M. Elevated blood pressure and decreased cognitive function among school-age children and adolescents in the United States. J Pediatr. 2003 Dec;143(6):720-4. doi: 10.1067/S0022-3476(03)00412-8.

  PMID: 14657815 BACKGROUND

• Miller RE, Shapiro AP, King HE, Ginchereau EH, Hosutt JA. Effect of antihypertensive treatment on the behavioral consequences of elevated blood pressure. Hypertension. 1984 Mar-Apr;6(2 Pt 1):202-8.

  PMID: 6724662 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marc B. Lande, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: January 1, 2010
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

US (1)