Obesity Clinical Trials

Find Obesity Clinical Trials Near You

Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE): The Role of Angiotensin-(1-7) in Hypertension and Hypertension-Induced Heart and Kidney Damage

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Studying the causal roles of components of the renin-angiotensin-aldosterone system (including angiotensin-(1-7) (Ang-(1-7)), angiotensin-converting enzyme 2 (ACE2), Ang II, and ACE), uric acid, and klotho in pediatric hypertension and related target organ injury, including in the heart, kidneys, vasculature, and brain. Recruiting children with a new hypertension diagnosis over a 2-year period from the Hypertension and Pediatric Nephrology Clinics affiliated with Brenner Children's Hospital at Atrium Health Wake Forest Baptist and Atrium Health Levine Children's Hospital. Healthy control participants will be recruited from local general primary care practices. Collecting blood and urine samples to analyze components of the renin-angiotensin-aldosterone system (Ang-(1-7), ACE2, Ang II, ACE), uric acid, and klotho, and measuring blood pressure, heart structure and function, autonomic function, vascular function, and kidney function at baseline, year 1, and year 2. Objectives are to investigate phenotypic and treatment response variability and to causally infer if Ang-(1-7), ACE2, Ang II, ACE, uric acid, and klotho contribute to target organ injury due to hypertension.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 18
Healthy Volunteers: t
View:

• 7-18 years of age at time of enrollment

• Confirmed new diagnosis of primary hypertension: no identifiable secondary cause, referred to hypertension or nephrology clinic

‣ Age \<13 years: BP ≥95th %ile or ≥130/80 mmHg (whichever is lower)

⁃ Age ≥13 years: BP ≥130/80 mmHg

• Participants and their caregivers must be willing and able to commit to completing the study assessments

• 7-18 years of age at time of enrollment

• Normal BP based on ≥3 prior office BP measurements on separate days;

‣ Age \<13 years: BP \<90th %ile or \<120/80 mmHg (whichever is lower)

⁃ Age ≥13 years: BP \<120/80 mmHg

• Participants and their caregivers must be willing and able to commit to completing the study assessments

Locations
United States
North Carolina
Wake Forest Health Sciences
RECRUITING
Winston-salem
Contact Information
Primary
Andrew M South, MD, MS
asouth@wakehealth.edu
336.716.9640
Backup
Caroline B Lucas
cblucas@wakehealth.edu
336.713.8038
Time Frame
Start Date: 2021-05-19
Estimated Completion Date: 2026-12
Participants
Target number of participants: 125
Treatments
Hypertension Cohort
Participants with newly diagnosed primary hypertension
Control Cohort
Healthy participants with normal blood pressure
Sponsors
Leads: Wake Forest University Health Sciences
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov