Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178490
Status:
COMPLETED
Last Update Posted:
2014-06-04
First Post:
2005-09-13
Brief Title:
Effect of High Blood Pressure and Antihypertensive Treatment on Brain Functioning in Children
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Neurocognitive Function in Children With Hypertension
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 parents 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 childs 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
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 parents 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 childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10361 | US NIH GrantContract | None | httpsreporternihgovquickSearchK23HL080068 |
| K23HL080068 | NIH | None | None |