Health TrialsbyHealthPanel

Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)

ConditionsHypertensionLeft Ventricular HypertrophyLeft Ventricular DysfunctionLeft Atrial DilatationLeft Ventricular Diastolic DysfunctionKidney DiseasesKidney InjuryKidney DysfunctionSodium Urine HighBlood Pressure DisordersUric Acid RetentionAngiotensin HypertensionAutonomic DysfunctionAutonomic ImbalancePediatric Kidney DiseasePediatric ObesityProteinuriaAlbuminuria
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-18
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

<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

Trial population

Hypertension Cohort: Participants will be recruited from among new patients referred to the Hypertension Clinic at Brenner Children's Hospital. Patient population at this clinic, which sees over 300 new patients/year, is 55% White, 25% Black, 16% Hispanic, and 62% male. Goal is to enroll 100 participants over a 2-year period. Control Cohort: Participants for this cohort will be recruited from among healthy patients seen at local pediatrics practices. Goal is to enroll 25 participants over a 2-year period, frequency-matched to the Hypertension Cohort on age, self-identified race, and sex.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

125 Participants
are grouped into 2 trial groups
Group A: Hypertension Cohort
Group B: Control Cohort

Trial outcomes

Primary outcomes

1

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

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).

Time frame
Baseline
2

Change in Urine Angiotensin-(1-7)/Creatinine Ratio

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).

Time frame
Baseline through 2 years
3

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

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).

Time frame
Baseline
4

Change in Urine Angiotensin II/Angiotensin-(1-7) Ratio

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).

Time frame
Baseline through 2 years

Secondary outcomes

1

Baseline Urine Angiotensin II/Creatinine Ratio

Urine angiotensin II 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).

Time frame
Baseline
2

Change in Urine Angiotensin II/Creatinine Ratio

Urine angiotensin II 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).

Time frame
Baseline through 2 years
3

Baseline Urine Angiotensin-Converting Enzyme 2 Level

Measure angiotensin-converting enzyme 2 content and enzymatic activity in first-morning urine samples using established fluorescence-based methods. 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).

Time frame
Baseline
4

Change in Urine Angiotensin-Converting Enzyme 2 Level

Measure angiotensin-converting enzyme 2 content and enzymatic activity in first-morning urine samples using established fluorescence-based methods. 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).

Time frame
Baseline through 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
Apply now