HypertensionPhase 1NCT00178490
Effect of High Blood Pressure and Antihypertensive Treatment on Brain Functioning in Children
A Phase 1 study testing High blood pressure treatment in people with Hypertension, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- High blood pressure treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester, Strong Memorial Hospital
Rochester, New York, 14642
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- High blood pressure treatment
- Keywords
- Neurocognitive Function
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High blood pressure treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Children with high blood pressure who will receive treatment for high blood pressure Receives: Drug: High blood pressure treatment |
| 2 | No intervention | Children with normal blood pressure who will undergo no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive function improvement with normalization of blood pressure
Measured: Measured at Month 12
Secondary outcomes (3)
Treatment of hypertension
Measured: Measured at Month 12
Correlation of neurocognitive deficits with the presence of cardiac hypertrophy, microalbuminuria, and hypertensive retinopathy
Measured: Measured at Month 12
Correlation of the presence of neurocognitive deficits with severity and pattern of hypertension
Measured: Measured at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJun 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Marc Lande, University of Rochester
- Investigators
- Marc B. Lande, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178490
- Sponsor's protocol ID
- 550
- Other IDs
- K23HL080068, 10361
- Status last verified
- Jun 2014
- First submitted
- 13 Sep 2005
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14657815Miller 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.
PubMed 6724662
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Function in Children With Hypertension
- ClinicalTrials.gov ID
- NCT00178490
- Acronym / sponsor ID
- 550
- Conditions
- Hypertension
- Keywords
- Neurocognitive Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: High blood pressure treatmentChildren with high blood pressure who will receive treatment for high blood pressure |
| 2 | No intervention | –Children with normal blood pressure who will undergo no treatment |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High blood pressure treatmentParticipants 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. | Drug | 1 |
Primary outcome
Neurocognitive function improvement with normalization of blood pressure
Time frame: Measured at Month 12
3 secondary outcomes
Treatment of hypertension
Time frame: Measured at Month 12
Correlation of neurocognitive deficits with the presence of cardiac hypertrophy, microalbuminuria, and hypertensive retinopathy
Time frame: Measured at Month 12
Correlation of the presence of neurocognitive deficits with severity and pattern of hypertension
Time frame: Measured at Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
- Background: PubMed 14657815Lande 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.
- Background: PubMed 6724662Miller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc B. Lande, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High blood pressure treatment in people with Hypertension, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive function improvement with normalization of blood pressure (time frame: Measured at Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00178490, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2014.