Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT04752293
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT04752293
Study Brief:
Protocol Section:
NCT04752293