Clinical trial NCT03305562: Pediatric Hypertension Registry (PHREG)
Official title: Pediatric Hypertension Registry (PHREG)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypertension
Pediatric Disorder
Keywords: Hypertension
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 179
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects that are patients in the Brenner Children's Hospital Pediatric Nephrology Clinic or Emory University Pediatric Nephrology with a confirmed diagnosis of high blood pressure.

Brief summary: Pediatric hypertension is increasingly common and is a precursor for adult cardiovascular and renal disease. But even during childhood, hypertension is associated with significant morbidity, including cognitive impairment and organ damage. However, the cause of pediatric hypertension, the response to treatment, and the mechanisms behind organ damage are incompletely understood. Due to these limitations, there are no first-line medications, and treatment is often inadequate. An improved comprehension of the course of pediatric hypertension could enhance clinical care. The goal of this proposal is to create a registry of patients with hypertension to better enable research into this important disease. This patient registry will enhance the investigators ability to quickly collect and analyze data for research studies.

Detailed description: The investigators will include all subjects evaluated at the Brenner Children's Hospital Pediatric Nephrology clinic since January 1st, 2013 with a diagnosis of high blood pressure confirmed with three separate blood pressure measurements \>=90th percentile for age, sex, and height, or \>120/80 mmHg. The investigators will exclude patients whose initial evaluation occurred on or after their 18th birthday.

Eligibility criteria: Inclusion Criteria:

- Patients at one of the following : Wake Forest Baptist Health Brenner Children's Hospital Pediatric Nephrology clinic Emory University Pediatric Nephrology

* Diagnosis of hypertension confirmed with three separate blood pressure measurements
* Diagnosis after January 2013
* \>90th percentile for age, sex, height, or \>120/80.

Exclusion Criteria:

- Patients whose initial evaluation occurred on or after their 18th birthday.

Primary outcomes:
measure: Blood pressure
timeFrame: 10 years
measure: Left ventricular hypertrophy
timeFrame: 10 years
measure: Albuminuria
timeFrame: 10 years
Secondary outcomes:
measure: Ambulatory blood pressure
timeFrame: 10 years
measure: Renal function
timeFrame: 10 years
measure: Uric acid
timeFrame: 10 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Pediatric Nephrology
state: Georgia
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Andrew M South, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Din-Dzietham R, Liu Y, Bielo MV, Shamsa F. High blood pressure trends in children and adolescents in national surveys, 1963 to 2002. Circulation. 2007 Sep 25;116(13):1488-96. doi: 10.1161/CIRCULATIONAHA.106.683243. Epub 2007 Sep 10.
citation: Richey PA, Disessa TG, Somes GW, Alpert BS, Jones DP. Left ventricular geometry in children and adolescents with primary hypertension. Am J Hypertens. 2010 Jan;23(1):24-9. doi: 10.1038/ajh.2009.164. Epub 2009 Oct 22.
citation: King JT Jr, DiLuna ML, Cicchetti DV, Tsevat J, Roberts MS. Cognitive functioning in patients with cerebral aneurysms measured with the mini mental state examination and the telephone interview for cognitive status. Neurosurgery. 2006 Oct;59(4):803-10; discussion 810-1. doi: 10.1227/01.NEU.0000232666.67779.41.
citation: Washburn LK, Nixon PA, Russell GB, Snively BM, O'Shea TM. Preterm Birth Is Associated with Higher Uric Acid Levels in Adolescents. J Pediatr. 2015 Jul;167(1):76-80. doi: 10.1016/j.jpeds.2015.03.043. Epub 2015 Apr 11.
citation: Feig DI, Soletsky B, Johnson RJ. Effect of allopurinol on blood pressure of adolescents with newly diagnosed essential hypertension: a randomized trial. JAMA. 2008 Aug 27;300(8):924-32. doi: 10.1001/jama.300.8.924.
citation: Mazzali M, Hughes J, Kim YG, Jefferson JA, Kang DH, Gordon KL, Lan HY, Kivlighn S, Johnson RJ. Elevated uric acid increases blood pressure in the rat by a novel crystal-independent mechanism. Hypertension. 2001 Nov;38(5):1101-6. doi: 10.1161/hy1101.092839.
citation: Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z, Wei R, Curtin LR, Roche AF, Johnson CL. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11. 2002 May;(246):1-190.
citation: Schwartz GJ, Brion LP, Spitzer A. The use of plasma creatinine concentration for estimating glomerular filtration rate in infants, children, and adolescents. Pediatr Clin North Am. 1987 Jun;34(3):571-90. doi: 10.1016/s0031-3955(16)36251-4.
citation: Flynn JT, Daniels SR, Hayman LL, Maahs DM, McCrindle BW, Mitsnefes M, Zachariah JP, Urbina EM; American Heart Association Atherosclerosis, Hypertension and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young. Update: ambulatory blood pressure monitoring in children and adolescents: a scientific statement from the American Heart Association. Hypertension. 2014 May;63(5):1116-35. doi: 10.1161/HYP.0000000000000007. Epub 2014 Mar 3. No abstract available.
citation: Khoury PR, Mitsnefes M, Daniels SR, Kimball TR. Age-specific reference intervals for indexed left ventricular mass in children. J Am Soc Echocardiogr. 2009 Jun;22(6):709-14. doi: 10.1016/j.echo.2009.03.003. Epub 2009 May 7.
citation: Rademacher ER, Sinaiko AR. Albuminuria in children. Curr Opin Nephrol Hypertens. 2009 May;18(3):246-51. doi: 10.1097/MNH.0b013e3283294b98.