Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Feb 11, 2021

Keywords

ClinConnect Summary

The Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE) trial is studying how certain biological components related to blood pressure can affect the health of children with high blood pressure, also known as hypertension. The researchers want to understand the roles of specific substances in the body that can impact the heart, kidneys, and other organs. They will be recruiting children aged 7 to 18 who have recently been diagnosed with primary hypertension, meaning there isn’t another identifiable cause for their high blood pressure. Healthy children in the same age group will also be recruited for comparison.

Participants in the study will have their blood pressure, heart, and kidney functions checked at the beginning and then again after one and two years. They will provide blood and urine samples for analysis. To be eligible, children must have a confirmed diagnosis of hypertension and be willing to participate in the assessments. Those with certain medical conditions or who do not speak English or Spanish cannot take part. This study aims to identify how different factors may contribute to health issues caused by hypertension and to see how children's responses to treatment may vary.

Gender

ALL

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 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