No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
7 – 18
Sex
Any
Study type
Observational
Participants needed
125 (estimated)
Sponsor
Wake Forest University Health Sciences · Other
Who this trial is looking for
This trial is looking for children aged 7 to 18 who have been diagnosed with high blood pressure. Participants will provide blood and urine samples and undergo various tests to help understand hypertension and its effects on the body.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 7 and 18 years old.
I have been diagnosed with new primary hypertension.
I have high blood pressure measurements.
I can complete the study assessments.
You may not be able to join if
I am younger than 7 or older than 18 years old.
I have normal or only elevated blood pressure.
I have a known secondary cause of high blood pressure.
I have a serious heart or kidney problem.
I cannot complete the study assessments.
I do not speak English or Spanish.
I am currently pregnant.
I am a ward of the state.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 fro…
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.
Trial Locations
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Eligibility Criteria
INCLUSION CRITERIA: HYPERTENSION COHORT
* 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 yea…
INCLUSION CRITERIA: HYPERTENSION COHORT
* 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
EXCLUSION CRITERIA: HYPERTENSION COHORT
* \<7 years or \>18 years of age at time of enrollment
* BP confirmed as normal or in the elevated BP category based on ≥3 prior office BP measurements on separate days;
* Age \<13 years: BP \<95th %ile or \<130/80 mmHg (whichever is lower)
* Age ≥13 years: BP \<130/80 mmHg
* A confirmed secondary cause of hypertension
* Confounding medical condition (heart or kidney disease \[except hypertension-associated heart changes on echocardiogram or albuminuria\], vascular/inflammatory disease, or diabetes)
* Inability to complete study assessments
* Non-English/Spanish speakers
* Current pregnancy
* Ward of the State
INCLUSION CRITERIA: CONTROL COHORT
* 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
EXCLUSION CRITERIA: CONTROL COHORT
* \<7 or \>18 years of age at time of enrollment
* Elevated BP or hypertension, 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
* History of elevated BP or hypertension
* Current use of BP-lowering medications
* Confounding medical condition (heart or kidney disease, vascular/inflammatory disease, or diabetes)
* Inability to complete study assessments
* Non-English/Spanish speakers
* Current pregnancy
* Ward of the State
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