|
|
View Clinical Trial (Medical Research Study)
|
Effect of High Blood Pressure and Antihypertensive Treatment on Brain Functioning in Children - NCT00178490-14642 (Clinical Trial 129077)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy129077.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Rochester |
|
State:
|
|
NY |
| Zip Code: |
|
14642 |
| Conditions: |
|
Hypertension |
| Purpose: |
|
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.
|
| Study summary: |
|
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. |
| Criteria: |
|
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 |
|
|
|
| Study is available at: |
|
University of Rochester, Strong Memorial Hospital
Rochester, NY 14642
United States
Primary Contact:
Marc B. Lande, MD
Email: marc_lande@urmc.rochester.edu
Phone: 585-275-9784
Secondary Contact:
Marc B. Lande, MD
Email: marc_lande@urmc.rochester.edu
Phone: 585-275-9784 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 15, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|