- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00178490
Effect of High Blood Pressure and Antihypertensive Treatment on Brain Functioning in Children
Neurocognitive Function in Children With Hypertension
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
New York
-
Rochester, New York, Forente stater, 14642
- University of Rochester, Strong Memorial Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Ingen inngripen: 2
Children with normal blood pressure who will undergo no treatment
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Neurocognitive function improvement with normalization of blood pressure
Tidsramme: Measured at Month 12
|
Measured at Month 12
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Treatment of hypertension
Tidsramme: Measured at Month 12
|
Measured at Month 12
|
Correlation of neurocognitive deficits with the presence of cardiac hypertrophy, microalbuminuria, and hypertensive retinopathy
Tidsramme: Measured at Month 12
|
Measured at Month 12
|
Correlation of the presence of neurocognitive deficits with severity and pattern of hypertension
Tidsramme: Measured at Month 12
|
Measured at Month 12
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Marc B. Lande, MD, University of Rochester
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 550
- K23HL080068 (U.S. NIH-stipend/kontrakt)
- 10361
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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