Understanding pediatric hypertension and its effects on the body
Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE): The Role of Angiotensin-(1-7) in Hypertension and Hypertension-Induced Heart and Kidney Damage
Wake Forest University Health Sciences · NCT04752293
This study looks at how different factors related to blood pressure affect children aged 7-18 who have just been diagnosed with high blood pressure, to see how it impacts their health over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 7 Years to 18 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT04752293 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the roles of various components of the renin-angiotensin-aldosterone system in children aged 7-18 with newly diagnosed primary hypertension. Over a two-year period, researchers will collect blood and urine samples and measure blood pressure, heart structure and function, kidney function, and other health indicators. The study aims to identify phenotypic and treatment response variability among participants and to explore the causal relationships between these components and target organ damage. Healthy control participants will also be recruited for comparison.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 7-18 years with a new diagnosis of primary hypertension.
Not a fit: Patients with secondary causes of hypertension or those outside the age range of 7-18 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of pediatric hypertension, potentially reducing long-term health complications.
How similar studies have performed: While there have been studies on hypertension in children, this specific approach focusing on the renin-angiotensin-aldosterone system is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Health Sciences — Winston-Salem, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Andrew M South, MD, MS — Wake Forest Health Sciences
- Study coordinator: Andrew M South, MD, MS
- Email: asouth@wakehealth.edu
- Phone: 336.716.9640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Left Ventricular Hypertrophy, Left Ventricular Dysfunction, Left Atrial Dilatation, Left Ventricular Diastolic Dysfunction, Kidney Diseases, Kidney Injury, Kidney Dysfunction