Clinical trial

Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)

Recruiting now · Not applicable · 1 countries · Registry ID NCT04752293

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age7 Years to 18 Years

SexAll

Healthy volunteersAccepted

ConditionHypertension, Left Ventricular Hypertrophy, Left Ventricular Dysfunction, Left Atrial Dilatation, Left Ventricular Diastolic Dysfunction, Kidney Diseases, Kidney Injury, Kidney Dysfunction, Sodium Urine High, Blood Pressure Disorders, Uric Acid Retention, Angiotensin Hypertension, Autonomic Dysfunction, Autonomic Imbalance, Pediatric Kidney Disease, Pediatric Obesity, Proteinuria, Albuminuria

Full registry 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 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

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Baseline Urine Angiotensin-(1-7)/Creatinine RatioBaseline

Urine angiotensin-(1-7) quantified by a highly developed radioimmunoassay well validated against mass spectrometry and standardized to urine creatinine, quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

Change in Urine Angiotensin-(1-7)/Creatinine RatioBaseline through 2 years

Baseline Urine Angiotensin II/Angiotensin-(1-7) RatioBaseline

Urine angiotensin II and angiotensin-(1-7) quantified by highly developed radioimmunoassays well validated against mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

Change in Urine Angiotensin II/Angiotensin-(1-7) RatioBaseline through 2 years

Baseline Plasma Angiotensin-(1-7) LevelBaseline

Plasma angiotensin-(1-7) quantified by a highly developed radioimmunoassay well validated against mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

Change in Plasma Angiotensin-(1-7) LevelBaseline through 2 years

Baseline Plasma Angiotensin II/Angiotensin-(1-7) RatioBaseline

Plasma angiotensin II and angiotensin-(1-7) quantified by highly developed radioimmunoassays well validated against mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

Change in Plasma Angiotensin II/Angiotensin-(1-7) RatioBaseline through 2 years

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Wake Forest Health Sciences🇺🇸 Winston-Salem, North Carolina, United States

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Andrew M South, MD, MSContact

Email · Call 336-716-9640

Caroline B LucasContact

Email · Call 336.713.8038

Andrew M South, MD, MSPrincipal Investigator