Pediatric Hypertension Registry (PHREG)

Hypertension Clinical Trial

— PHREG  

Official title:

Pediatric Hypertension Registry (PHREG)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03305562
• Other study ID #: IRB00046001
• Status: Terminated
• Start date: September 20, 2017
• Est. completion date: June 22, 2021

Study information

• Verified date: June 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 179
• Est. completion date: June 22, 2021
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Pediatric Disorder

Locations

Country	Name	City	State
United States	Emory University Pediatric Nephrology	Atlanta	Georgia
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Rademacher ER, Sinaiko AR. Albuminuria in children. Curr Opin Nephrol Hypertens. 2009 May;18(3):246-51. doi: 10.1097/MNH.0b013e3283294b98. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Auscultated blood pressure measurements in clinic	10 years
Primary	Left ventricular hypertrophy	Left ventricular hypertrophy and other cardiac structural/function changes on echocardiograms	10 years
Primary	Albuminuria	Urinary albumin-to-creatinine (>30 mg/g)	10 years
Secondary	Ambulatory blood pressure	Ambulatory blood pressure monitoring data	10 years
Secondary	Renal function	Glomerular filtration rate	10 years
Secondary	Uric acid	Serum uric acid	10 years