NCT03305562

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2021

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

3.8 years

First QC Date

September 27, 2017

Last Update Submit

June 8, 2023

Conditions

HypertensionPediatric Disorder

Keywords

Hypertension

Outcome Measures

Primary Outcomes (3)

  • Blood pressure

    Auscultated blood pressure measurements in clinic

    10 years

  • Left ventricular hypertrophy

    Left ventricular hypertrophy and other cardiac structural/function changes on echocardiograms

    10 years

  • Albuminuria

    Urinary albumin-to-creatinine (\>30 mg/g)

    10 years

Secondary Outcomes (3)

  • Ambulatory blood pressure

    10 years

  • Renal function

    10 years

  • Uric acid

    10 years

Study Arms (2)

Retrospective cohort

The cohort of patients seen prior to the implementation of a standardized clinical management protocol on 10/01/2017 whose data is collected retrospectively.

Prospective cohort

The cohort of patients seen initially seen after implementation of a standardized clinical management protocol on 10/01/2017 whose data is collected prospectively.

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • \- 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University Pediatric Nephrology

Atlanta, Georgia, 30322, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related 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.

    PMID: 17846287BACKGROUND

  • 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.

    PMID: 19851297BACKGROUND

  • 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.

    PMID: 17038944BACKGROUND

  • 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.

    PMID: 25868431BACKGROUND

  • 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.

    PMID: 18728266BACKGROUND

  • 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.

    PMID: 11711505BACKGROUND

  • 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.

    PMID: 12043359BACKGROUND

  • 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.

    PMID: 3588043BACKGROUND

  • 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.

    PMID: 24591341BACKGROUND

  • 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.

    PMID: 19423289BACKGROUND

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

    PMID: 19276802BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Andrew M South, MD MS

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 10, 2017

Study Start

September 20, 2017

Primary Completion

June 22, 2021

Study Completion

June 22, 2021

Last Updated

June 12, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)