Pediatric Hypertension Registry (PHREG) (PHREG)

June 8, 2023 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

179

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Pediatric Nephrology
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 17 years (Child)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 10 years
Auscultated blood pressure measurements in clinic
10 years
Left ventricular hypertrophy
Time Frame: 10 years
Left ventricular hypertrophy and other cardiac structural/function changes on echocardiograms
10 years
Albuminuria
Time Frame: 10 years
Urinary albumin-to-creatinine (>30 mg/g)
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ambulatory blood pressure
Time Frame: 10 years
Ambulatory blood pressure monitoring data
10 years
Renal function
Time Frame: 10 years
Glomerular filtration rate
10 years
Uric acid
Time Frame: 10 years
Serum uric acid
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Andrew M South, MD MS, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2017

Primary Completion (Actual)

June 22, 2021

Study Completion (Actual)

June 22, 2021

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

October 3, 2017

First Posted (Actual)

October 10, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00046001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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