High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing.
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|ClinicalTrials.gov Identifier: NCT03696654|
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Sleep Disorder; Breathing-Related||Procedure: adenotonsillar surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||286 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||The control system of measurements will be before and after treatment on the same group of patients (children with SDB and indication for adeno-tonsillectomy). For the analysis of the main variable (mean systolic blood pressure-BP), baseline values will be obtained through ambulatory blood pressure monitoring (ABPM) and pulse transit time (PTT) in the basal visit. In order to evaluate the impact of treatment of SDB (adeno-tonsillar surgery) on BP, the measurement will be repeated just before the surgical intervention (ABPM and PTT) and six months after surgery (ABPM and PTT) in the same group. In this way, a control group will be available (measurements just before the surgery / control group) that will be compared with the measurements of those same patients six months after the surgery (treatment group). This measure allows having control values without preventing the treatment of any patient and without causing delays in the application of the same linked to the study|
|Masking:||None (Open Label)|
|Official Title:||Prevalence of High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing. Reversibility After Treatment (The Kids TRIAL STUDY).|
|Actual Study Start Date :||February 19, 2019|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||November 2021|
|No Intervention: Before treatment|
|Active Comparator: After treatment||
Procedure: adenotonsillar surgery
when indicated, adenotonsillar surgery for SDB treatment
- Mean systolic blood pressure [ Time Frame: 6 months ]Demonstrate how the presence of SDB is associated with an increased risk of HBP in pediatric patients. Confirm that it is reversible with the treatment
- Apnea hypopnea index [ Time Frame: 6 months ]Establish the relationship between the presence of hypertension and the severity of SDB (apnea-hypopnea index-AHI, desaturation index-DI).
- Percentage of change of mean systolic blood pressure between day and night [ Time Frame: 6 months ]To evaluate the variability along the circadian rhythm of the HBP patterns produced in pediatric patients with SDB
- blood pressure in clinic [ Time Frame: 6 months ]Establish the correlation between the diagnosis of HBP measured in the clinic and ambulatory blood pressure measurement (ABPM).
- creatinine / glomerular filtration, albuminuria / proteinuria and left ventricle hypertrophy. [ Time Frame: 6 months ]Assess the manifestation of subclinical organic damage by means of other markers such as: blood (creatinine / glomerular filtration), urine (albuminuria / proteinuria) and echocardiography (left ventricle hypertrophy).
- Pulse transit time [ Time Frame: 6 months ]Validate the pulse transit time (PTT) measurement as arterial pressure monitoring.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696654
|Contact: Olga Mediano, MD||+34 email@example.com|
|Hospital Universitario de Guadalajara||Recruiting|
|Guadalajara, Spain, 19002|
|Contact: Olga Mediano, MD|