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HypertensionPHRASENCT04752293

Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)

An observational study of Hypertension and Left Ventricular Hypertrophy, run by Wake Forest University Health Sciences at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 7 to 18 yearsHealthy volunteers can take part
How many people
125 participants
Where
1 siteUnited States
Study dates
19 May 2021to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study 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.

Who may be able to join

  • 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
  • 7-18 years of age at time of enrollment
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  • 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

Who cannot join

  • <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)
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  • Inability to complete study assessments
  • Non-English/Spanish speakers
  • Current pregnancy
  • Ward of the State
  • <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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrew M South, MD, MS contact

336.716.9640

asouth@wakehealth.edu

Caroline B Lucas contact

336.713.8038

cblucas@wakehealth.edu

United States1 site, 1 recruiting

  • Wake Forest Health Sciences

    Winston-Salem, North Carolina, 27157

    Andrew M South, MD, MS, 336-716-9640, asouth@wakehealth.edu

    Caroline B Lucas, 336.713.8038, cblucas@wakehealth.edu

    Recruiting

Other trials in United States

About this study

Official title: Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE): The Role of Angiotensin-(1-7) in Hypertension and Hypertension-Induced Heart and Kidney Damage

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.

Read the detailed description

This longitudinal prospective cohort study is recruiting children and adolescents aged 7-18 years with newly diagnosed primary hypertension over a 2-year period from the Hypertension and Pediatric Nephrology Clinics affiliated with Brenner Children's Hospital at Atrium Health Wake Forest Baptist, which sees over 300 new patients a year, and the Pediatric Nephrology Clinic at Atrium Health Levine Children's Hospital (Hypertension Cohort). Also recruiting healthy control participants aged 7-18 years with normal blood pressure from local primary care practices (Control Cohort). Collecting blood and urine to analyze Ang-(1-7), ACE2, Ang II, ACE, uric acid, and klotho and measuring pediatric-specific outcomes (blood pressure (casual and ambulatory monitoring), indices of heart structure and function on echocardiogram (left ventricular systolic and diastolic function, left ventricular hypertrophy, etc.), kidney function (creatinine, estimated glomerular filtration rate, albuminuria, proteinuria, urine sodium/potassium), autonomic function (heart rate variability, blood pressure variability, baroreflex sensitivity), and vascular function (arterial stiffness, augmentation index)) at baseline and year 1 (Hypertension Cohort and Control Cohort) and year 2 (Hypertension Cohort). The objectives are to investigate if Ang-(1-7), ACE2, Ang II, and ACE identify 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, with these Specific Aims:

Aim 1:

(1) Determine if plasma Ang-(1-7) or urine Ang-(1-7)/creatinine differ between the Hypertension vs. Control Cohorts and (2) assess if plasma Ang-(1-7) or urine Ang-(1-7)/creatinine mediate the effect of lisinopril-induced blood pressure reduction on the outcomes (change in heart function and structure, autonomic function, vascular function, and kidney function).

Hypothesis 1a: Baseline Ang-(1-7) is lower in the Hypertension vs. Control Cohort.

Hypothesis 1b: Increased Ang-(1-7) levels over time mediate the effect of lisinopril-induced decreased blood pressure on improved outcomes over 2 years in the Hypertension Cohort.

Aim 2:

(1) Evaluate if plasma Ang-(1-7) or urine Ang-(1-7)/creatinine predict treatment response in participants in the Hypertension Cohort (change in casual blood pressure, ambulatory blood pressure, heart function/structure, autonomic function, vascular function, and kidney function); (2) compare to plasma renin activity and aldosterone; and (3) employ sensitivity analyses to quantify the impact of unmeasured confounding.

Hypothesis 2: Lower baseline Ang-(1-7) predicts greater outcome improvements in the Hypertension Cohort with lower unmeasured confounding and with greater predictive ability compared to plasma renin activity and aldosterone.

Aim 3:

Determine if plasma Ang-(1-7) or urine Ang-(1-7)/creatinine mediate the effects of uric acid and klotho on the outcomes in participants in the Hypertension Cohort. (1) Apply causal mediation to estimate if plasma Ang-(1-7) mediates the effects of uric acid on the outcomes (change in casual blood pressure, ambulatory blood pressure, heart function/structure, autonomic function, and vascular function). (2) Apply causal mediation to estimate if urine Ang-(1-7)/creatinine mediates the effects of klotho on the outcomes (change in casual blood pressure, ambulatory blood pressure, and kidney function).

Hypothesis 3a: Lower plasma Ang-(1-7) mediates the effect of high uric acid on the outcomes in the Hypertension Cohort.

Hypothesis 3b: Lower urine Ang-(1-7)/creatinine mediates the effect of low klotho on the outcomes in the Hypertension Cohort.

Anticipated results have great potential to impact patient care by establishing Ang-(1-7), ACE2, Ang II, and ACE as biomarkers of treatment response, by establishing how Ang-(1-7) and other components of the renin-angiotensin-aldosterone system change in response to an ACE inhibitor, by indicating which patients would benefit most from ACE inhibitors, by identifying novel etiologies of hypertension centered on alterations to the renin-angiotensin-aldosterone system, uric acid, and klotho, and by leading to novel treatments. Indeed, these have been questions of great interest during the COVID-19 pandemic, as ACE2 is the binding site for Severe acute respiratory syndrome (SARS)-CoV-2. Ultimately, the results from this study will improve patient outcomes by promoting cardiovascular health and preventing cardiovascular disease across the lifecourse.

Keywords
High Blood Pressure, Elevated Blood Pressure, Hypertension, Pediatric Hypertension, Target Organ Damage, Left Ventricular Hypertrophy, Albuminuria, Uric Acid, Klotho, Fibroblast Growth Factor 23, Renin-Angiotensin-Aldosterone System, Renin-Angiotensin System, Angiotensin-(1-7), Angiotensin II, Angiotensin-Converting Enzyme 2, Angiotensin-Converting Enzyme, Causal Inference, Causal Mediation Analysis, Sensitivity Analysis, Predictive Analysis
Medical subject headings
Hypertension, Hypertrophy, Left Ventricular, Ventricular Dysfunction, Left, Kidney Diseases, Hyperuricemia, Primary Dysautonomias, Pediatric Obesity, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04752293
Study groupRoleWhat they receive
Hypertension CohortParticipants with newly diagnosed primary hypertension
Control CohortHealthy participants with normal blood pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: Baseline through 2 years

  5. Baseline Plasma Angiotensin-(1-7) Level

    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).

    Measured: Baseline

  6. Change in Plasma Angiotensin-(1-7) Level

    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).

    Measured: Baseline through 2 years

  7. Baseline Plasma Angiotensin II/Angiotensin-(1-7) Ratio

    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).

    Measured: Baseline

  8. Change in Plasma Angiotensin II/Angiotensin-(1-7) Ratio

    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).

    Measured: Baseline through 2 years

  9. Baseline Serum Uric Acid Level

    Serum uric acid quantified by a validated uricase assay. Report as a continuous variable with measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).

    Measured: Baseline

  10. Change in Serum Uric Acid Level

    Serum uric acid quantified by a validated uricase assay. Report as a continuous variable with measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).

    Measured: Baseline through 2 years

  11. Baseline Plasma Klotho Level

    Plasma α-klotho quantified by a well-validated ELISA. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  12. Change in Plasma Klotho Level

    Plasma α-klotho quantified by a well-validated ELISA. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  13. Baseline Urine Klotho/Creatinine Ratio

    Urine α-klotho quantified by a well-validated ELISA 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).

    Measured: Baseline

  14. Change in Urine Klotho/Creatinine Ratio

    Urine α-klotho quantified by a well-validated ELISA 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).

    Measured: Baseline through 2 years

  15. Baseline Manual Systolic Blood Pressure

    Average of 3 manual measurements per national guidelines. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).

    Measured: Baseline

  16. Change in Manual Systolic Blood Pressure

    Average of 3 manual measurements per national guidelines. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).

    Measured: Baseline through 2 years

  17. Baseline Manual Diastolic Blood Pressure

    Average of 3 manual measurements per national guidelines. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).

    Measured: Baseline

  18. Change in Manual Diastolic Blood Pressure

    Average of 3 manual measurements per national guidelines. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).

    Measured: Baseline through 2 years

  19. Baseline Manual Systolic Blood Pressure Z-score

    Average of 3 manual measurements per national guidelines with calculated z-score referenced to normative values by age, sex, and height. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).

    Measured: Baseline

  20. Change in Manual Systolic Blood Pressure Z-score

    Average of 3 manual measurements per national guidelines with calculated z-score referenced to normative values by age, sex, and height. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).

    Measured: Baseline through 2 years

  21. Baseline Manual Diastolic Blood Pressure Z-score

    Average of 3 manual measurements per national guidelines with calculated z-score referenced to normative values by age, sex, and height. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).

    Measured: Baseline

  22. Change in Manual Diastolic Blood Pressure Z-score

    Average of 3 manual measurements per national guidelines with calculated z-score referenced to normative values by age, sex, and height. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).

    Measured: Baseline through 2 years

  23. Baseline Ambulatory Systolic Blood Pressure 24-Hour Mean

    Measured via ambulatory blood pressure (BP) monitoring. Average systolic BP over a 24-hour period. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  24. Change in Ambulatory Systolic Blood Pressure 24-Hour Mean

    Measured via ambulatory blood pressure (BP) monitoring. Average systolic BP over a 24-hour period. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  25. Baseline Ambulatory Diastolic Blood Pressure 24-Hour Mean

    Measured via ambulatory blood pressure (BP) monitoring. Average diastolic BP over a 24-hour period. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  26. Change in Ambulatory Diastolic Blood Pressure 24-Hour Mean

    Measured via ambulatory blood pressure (BP) monitoring. Average diastolic BP over a 24-hour period. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  27. Baseline Left Ventricular Mass Height Index

    Left ventricular mass measured via echocardiogram and indexed to height as g/m^2.7. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  28. Change in Left Ventricular Mass Height Index

    Left ventricular mass measured via echocardiogram and indexed to height as g/m^2.7. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  29. Baseline Left Ventricular Mass Body Surface Area Index

    Left ventricular mass measured via echocardiogram and indexed to body surface area (BSA) as g/BSA. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  30. Change in Left Ventricular Mass Body Surface Area Index

    Left ventricular mass measured via echocardiogram and indexed to body surface area (BSA) as g/BSA. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  31. Baseline Left Ventricular Hypertrophy

    Measured via echocardiogram. Binary variable defined as left ventricular mass index (LVMI) >51 g/m^2.7 (all participants), >115 g/body surface area (BSA) (males), or >95 g/BSA (females), per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline

  32. Change in Left Ventricular Hypertrophy

    Measured via echocardiogram. Binary variable defined as left ventricular mass index (LVMI) >51 g/m^2.7 (all participants), >115 g/body surface area (BSA) (males), or >95 g/BSA (females), per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline through 2 years

  33. Baseline Urine Albumin/Creatinine Ratio

    Measured in fasting first-morning urine samples. Albumin analyzed in the Clinical Laboratory and creatinine analyzed via 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).

    Measured: Baseline

  34. Change in Urine Albumin/Creatinine Ratio

    Measured in fasting first-morning urine samples. Albumin analyzed in the Clinical Laboratory and creatinine analyzed via 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).

    Measured: Baseline through 2 years

  35. Baseline Albuminuria

    Measured in fasting first-morning urine samples. Albumin analyzed in the Clinical Laboratory and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Binary variable defined as an albumin/creatinine ratio >30 mg/g. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline

  36. Change in Albuminuria

    Measured in fasting first-morning urine samples. Albumin analyzed in the Clinical Laboratory and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Binary variable defined as an albumin/creatinine ratio >30 mg/g. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline through 2 years

  37. Baseline Serum Creatinine Level

    Measured in the serum and analyzed via 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).

    Measured: Baseline

  38. Change in Serum Creatinine Level

    Measured in the serum and analyzed via 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).

    Measured: Baseline through 2 years

  39. Baseline Estimated Glomerular Filtration Rate

    Estimated using validated, non-race-based, age-appropriate equations (modified Schwartz equation and height- and age-based full-age-spectrum equations with serum creatinine (analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry) and serum cystatin C (analyzed via the Clinical Laboratory). Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  40. Change in Estimated Glomerular Filtration Rate

    Estimated using validated, non-race-based, age-appropriate equations (modified Schwartz equation and height- and age-based full-age-spectrum equations with serum creatinine (analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry) and serum cystatin C (analyzed via the Clinical Laboratory). Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  41. Baseline Urine Sodium Concentration

    Measured sodium and creatinine in fasting, first-morning urine samples. Sodium analyzed in the Clinical Laboratory, and creatinine analyzed via 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).

    Measured: Baseline

  42. Change in Urine Sodium Concentration

    Measured sodium and creatinine in fasting, first-morning urine samples. Sodium analyzed in the Clinical Laboratory, and creatinine analyzed via 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).

    Measured: Baseline through 2 years

  43. Baseline Urine Sodium/Potassium Ratio

    Measured sodium and potassium in fasting, first-morning urine samples and analyzed in the Clinical Laboratory. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  44. Change in Urine Sodium/Potassium Ratio

    Measured sodium and potassium in fasting, first-morning urine samples and analyzed in the Clinical Laboratory. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  45. Baseline Plasma Renin Activity

    Measured in the plasma with a well-validated assay. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  46. Change in Plasma Renin Activity

    Measured in the plasma with a well-validated assay. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  47. Baseline Serum Aldosterone Level

    Measured in the serum with a well-validated assay. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  48. Change in Serum Aldosterone Level

    Measured in the serum with a well-validated assay. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

Secondary outcomes (105)

  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).

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: Baseline through 2 years

  5. Baseline Urine Angiotensin-Converting Enzyme Level

    Measure angiotensin-converting enzyme 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).

    Measured: Baseline

  6. Change in Urine Angiotensin-Converting Enzyme Level

    Measure angiotensin-converting enzyme 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).

    Measured: Baseline through 2 years

  7. Baseline Urine Angiotensin-Converting Enzyme/Angiotensin-Converting Enzyme 2 Ratio

    Measure angiotensin-converting enzyme and angiotensin-converting enzyme 2 content and enzymatic activity in first-morning urine samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  8. Change in Urine Angiotensin-Converting Enzyme/Angiotensin-Converting Enzyme 2 Ratio

    Measure angiotensin-converting enzyme and angiotensin-converting enzyme 2 content and enzymatic activity in first-morning urine samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  9. Baseline Plasma Angiotensin II Level

    Plasma angiotensin II 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).

    Measured: Baseline

  10. Change in Plasma Angiotensin II Level

    Plasma angiotensin II 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).

    Measured: Baseline through 2 years

  11. Baseline Serum Angiotensin-Converting Enzyme 2 Level

    Measure angiotensin-converting enzyme 2 content and enzymatic activity in serum samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  12. Change in Serum Angiotensin-Converting Enzyme 2 Level

    Measure angiotensin-converting enzyme 2 content and enzymatic activity in serum samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  13. Baseline Serum Angiotensin-Converting Enzyme Level

    Measure angiotensin-converting enzyme content and enzymatic activity in serum samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  14. Change in Serum Angiotensin-Converting Enzyme Level

    Measure angiotensin-converting enzyme content and enzymatic activity in serum samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  15. Baseline Serum Angiotensin-Converting Enzyme/Angiotensin-Converting Enzyme 2 Ratio

    Measure angiotensin-converting enzyme and angiotensin-converting enzyme 2 content and enzymatic activity in serum samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  16. Change in Serum Angiotensin-Converting Enzyme/Angiotensin-Converting Enzyme 2 Ratio

    Measure angiotensin-converting enzyme and angiotensin-converting enzyme 2 content and enzymatic activity in serum samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  17. Baseline Hyperuricemia

    Serum uric acid quantified by a validated uricase assay. Hyperuricemia defined as ≥8.0 mg/dl, reported with relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline

  18. Change in Hyperuricemia

    Serum uric acid quantified by a validated uricase assay. Hyperuricemia defined as ≥8.0 mg/dl, reported with relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline through 2 years

  19. Baseline Manual Blood Pressure Classification

    Based on average of 3 manual blood pressure (BP) measurements per age-specific national guidelines and age, sex, and height-based BP percentile. Categorized as a 4-level ordinal variable: (1) normal, <90th percentile or <120/80 mmHg; (2) elevated BP, ≥90th to <95th percentile or 120-129/<80 mmHg; (3) stage 1 hypertension, ≥95th to <95th percentile + 12 mmHg or 130-139/80-89 mmHg; (4) stage 2 hypertension, ≥95th percentile + 12 mmHg or ≥140/90 mmHg). Report relative measures (e.g., odds ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline

  20. Change in Manual Blood Pressure Classification

    Based on average of 3 manual blood pressure (BP) measurements per age-specific national guidelines and age, sex, and height-based BP percentile. Categorized as a 4-level ordinal variable: (1) normal, <90th percentile or <120/80 mmHg; (2) elevated BP, ≥90th to <95th percentile or 120-129/<80 mmHg; (3) stage 1 hypertension, ≥95th to <95th percentile + 12 mmHg or 130-139/80-89 mmHg; (4) stage 2 hypertension, ≥95th percentile + 12 mmHg or ≥140/90 mmHg). Report relative measures (e.g., odds ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline through 2 years

  21. Baseline Ambulatory Systolic Blood Pressure 24-Hour Load

    Measured via ambulatory blood pressure (BP) monitoring. Proportion of systolic BP readings over a 24-hour period that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  22. Change in Ambulatory Systolic Blood Pressure 24-Hour Load

    Measured via ambulatory blood pressure (BP) monitoring. Proportion of systolic BP readings over a 24-hour period that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  23. Baseline Ambulatory Diastolic Blood Pressure 24-Hour Load

    Measured via ambulatory blood pressure (BP) monitoring. Proportion of diastolic BP readings over a 24-hour period that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  24. Change in Ambulatory Diastolic Blood Pressure 24-Hour Load

    Measured via ambulatory blood pressure (BP) monitoring. Proportion of diastolic BP readings over a 24-hour period that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  25. Baseline Ambulatory Systolic Blood Pressure 24-Hour Index

    Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP over 24-hour period divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  26. Change in Ambulatory Systolic Blood Pressure 24-Hour Index

    Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP over 24-hour period divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  27. Baseline Ambulatory Diastolic Blood Pressure 24-Hour Index

    Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP over 24-hour period divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  28. Change in Ambulatory Diastolic Blood Pressure 24-Hour Index

    Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP over 24-hour period divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  29. Baseline Ambulatory Systolic Blood Pressure Awake Mean

    Measured via ambulatory blood pressure (BP) monitoring. Average systolic BP while awake. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  30. Change in Ambulatory Systolic Blood Pressure Awake Mean

    Measured via ambulatory blood pressure (BP) monitoring. Average systolic BP while awake. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  31. Baseline Ambulatory Diastolic Blood Pressure Awake Mean

    Measured via ambulatory blood pressure (BP) monitoring. Average diastolic BP while awake. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  32. Change in Ambulatory Diastolic Blood Pressure Awake Mean

    Measured via ambulatory blood pressure (BP) monitoring. Average diastolic BP while awake. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  33. Baseline Ambulatory Systolic Blood Pressure Awake Load

    Measured via ambulatory blood pressure (BP) monitoring. Proportion of systolic BP readings while awake that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  34. Change in Ambulatory Systolic Blood Pressure Awake Load

    Measured via ambulatory blood pressure (BP) monitoring. Proportion of systolic BP readings while awake that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  35. Baseline Ambulatory Diastolic Blood Pressure Awake Load

    Measured via ambulatory blood pressure (BP) monitoring. Proportion of diastolic BP readings while awake that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  36. Change in Ambulatory Diastolic Blood Pressure Awake Load

    Measured via ambulatory blood pressure (BP) monitoring. Proportion of diastolic BP readings while awake that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  37. Baseline Ambulatory Systolic Blood Pressure Awake Index

    Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while awake divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  38. Change in Ambulatory Systolic Blood Pressure Awake Index

    Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while awake divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  39. Baseline Ambulatory Diastolic Blood Pressure Awake Index

    Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while awake divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  40. Change in Ambulatory Diastolic Blood Pressure Awake Index

    Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while awake divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  41. Baseline Ambulatory Systolic Blood Pressure Asleep Mean

    Measured via ambulatory blood pressure (BP) monitoring. Average systolic BP while asleep. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  42. Change in Ambulatory Systolic Blood Pressure Asleep Mean

    Measured via ambulatory blood pressure (BP) monitoring. Average systolic BP while asleep. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  43. Baseline Ambulatory Diastolic Blood Pressure Asleep Mean

    Measured via ambulatory blood pressure (BP) monitoring. Average diastolic BP while asleep. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  44. Change in Ambulatory Diastolic Blood Pressure Asleep Mean

    Measured via ambulatory blood pressure (BP) monitoring. Average diastolic BP while asleep. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  45. Baseline Ambulatory Systolic Blood Pressure Asleep Load

    Measured via ambulatory blood pressure (BP) monitoring. Proportion of systolic BP readings while asleep that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  46. Change in Ambulatory Systolic Blood Pressure Asleep Load

    Measured via ambulatory blood pressure (BP) monitoring. Proportion of systolic BP readings while asleep that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  47. Baseline Ambulatory Diastolic Blood Pressure Asleep Load

    Measured via ambulatory blood pressure (BP) monitoring. Proportion of diastolic BP readings while asleep that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  48. Change in Ambulatory Diastolic Blood Pressure Asleep Load

    Measured via ambulatory blood pressure (BP) monitoring. Proportion of diastolic BP readings while asleep that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  49. Baseline Ambulatory Systolic Blood Pressure Asleep Index

    Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while asleep divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  50. Change in Ambulatory Systolic Blood Pressure Asleep Index

    Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while asleep divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  51. Baseline Ambulatory Diastolic Blood Pressure Asleep Index

    Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while asleep divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  52. Change in Ambulatory Diastolic Blood Pressure Asleep Index

    Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while asleep divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  53. Baseline Ambulatory Systolic Blood Pressure Nocturnal Dipping

    Measured via ambulatory blood pressure (BP) monitoring. Proportion calculated as ([ mean awake - mean asleep systolic BP ] / [mean awake systolic BP ]) x 100, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  54. Change in Ambulatory Systolic Blood Pressure Nocturnal Dipping

    Measured via ambulatory blood pressure (BP) monitoring. Proportion calculated as ([ mean awake - mean asleep systolic BP ] / [mean awake systolic BP ]) x 100, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  55. Baseline Ambulatory Diastolic Blood Pressure Nocturnal Dipping

    Measured via ambulatory blood pressure (BP) monitoring. Proportion calculated as ([ mean awake - mean asleep diastolic BP ] / [mean awake diastolic BP ]) x 100, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  56. Change in Ambulatory Diastolic Blood Pressure Nocturnal Dipping

    Measured via ambulatory blood pressure (BP) monitoring. Proportion calculated as ([ mean awake - mean asleep diastolic BP ] / [mean awake diastolic BP ]) x 100, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  57. Baseline Ambulatory Inadequate Nocturnal Dipping

    Measured via ambulatory blood pressure (BP) monitoring. Binary variable defined as the proportion of BP nocturnal dipping <10 percent, per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline

  58. Change in Ambulatory Inadequate Nocturnal Dipping

    Measured via ambulatory blo od pressure (BP) monitoring. Binary variable defined as the proportion of BP nocturnal dipping <10 percent, per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline through 2 years

  59. Baseline Ambulatory Hypertension

    Measured via ambulatory blood pressure (BP) monitoring. Binary variable defined as mean BP ≥95 percentile for height AND load ≥25 percent for any time period, per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline

  60. Change in Ambulatory Hypertension

    Measured via ambulatory blood pressure (BP) monitoring. Binary variable defined as mean BP ≥95 percentile for height AND load ≥25 percent for any time period, per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline through 2 years

  61. Baseline Relative Left Ventricular Wall Thickness

    Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  62. Change in Relative Left Ventricular Wall Thickness

    Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  63. Baseline Elevated Relative Left Ventricular Wall Thickness

    Measured via echocardiogram. Binary variable defined as >0.42, per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline

  64. Change in Elevated Relative Left Ventricular Wall Thickness

    Measured via echocardiogram. Binary variable defined as >0.42, per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline through 2 years

  65. Baseline Left Ventricular Geometry Classification

    Measured via echocardiogram. 4-level ordinal variable defined as (1) normal (normal left ventricular mass index (LVMI) and normal relative left ventricular wall thickness (RLVWT)); 2) concentric remodeling (normal LVMI and high RLVWT); 3) eccentric hypertrophy (high LVMI and normal RLVWT); 4) concentric hypertrophy (high LVMI and high RLVWT), per national guidelines. Report relative measures (e.g., risk ratio, odds ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline

  66. Change in Left Ventricular Geometry Classification

    Measured via echocardiogram. 4-level ordinal variable defined as (1) normal (normal left ventricular mass index (LVMI) and normal relative left ventricular wall thickness (RLVWT)); 2) concentric remodeling (normal LVMI and high RLVWT); 3) eccentric hypertrophy (high LVMI and normal RLVWT); 4) concentric hypertrophy (high LVMI and high RLVWT), per national guidelines. Report relative measures (e.g., risk ratio, odds ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline through 2 years

  67. Baseline Left Ventricular Systolic Function

    Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  68. Change in Left Ventricular Systolic Function

    Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  69. Baseline Left Ventricular Diastolic Function

    Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  70. Change in Left Ventricular Diastolic Function

    Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  71. Baseline Left Atrial Size

    Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  72. Change in Left Atrial Size

    Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  73. Baseline Left Atrial Enlargement

    Measured via echocardiogram. Binary variable defined ≥29 ml/m^2, per national guidelines. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline

  74. Change in Left Atrial Enlargement

    Measured via echocardiogram. Binary variable defined ≥29 ml/m^2, per national guidelines. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline through 2 years

  75. Baseline Urine Protein/Creatinine Ratio

    Measured in fasting first-morning urine samples. Protein analyzed in the Clinical Laboratory and creatinine analyzed via 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).

    Measured: Baseline

  76. Change in Urine Protein/Creatinine Ratio

    Measured in fasting first-morning urine samples. Protein analyzed in the Clinical Laboratory and creatinine analyzed via 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).

    Measured: Baseline through 2 years

  77. Baseline Proteinuria

    Measured in fasting first-morning urine samples. Protein analyzed in the Clinical Laboratory and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Binary variable defined as a protein/creatinine ratio >0.2 mg/mg. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline

  78. Change in Proteinuria

    Measured in fasting first-morning urine samples. Protein analyzed in the Clinical Laboratory and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Binary variable defined as a protein/creatinine ratio >0.2 mg/mg. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline through 2 years

  79. Baseline Serum Cystatin C Level

    Measured in the serum and analyzed via the Clinical Laboratory. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline

  80. Change in Serum Cystatin C Level

    Measured in the serum and analyzed via the Clinical Laboratory. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).

    Measured: Baseline through 2 years

  81. Baseline Elevated Urine Sodium Concentration

    Measured sodium and creatinine in fasting, first-morning urine samples. Sodium analyzed in the Clinical Laboratory, and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Binary variable defined as urine sodium/creatinine ratio >1 mmol/mg. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline

  82. Change in Elevated Urine Sodium Concentration

    Measured sodium and creatinine in fasting, first-morning urine samples. Sodium analyzed in the Clinical Laboratory, and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Binary variable defined as urine sodium/creatinine ratio >1 mmol/mg. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline through 2 years

  83. Baseline Elevated Urine Sodium/Potassium Ratio

    Measured sodium and potassium in fasting, first-morning urine samples and analyzed in the Clinical Laboratory. Binary variable defined as urine sodium/potassium ratio >1 mmol/mmol. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline

  84. Change in Elevated Urine Sodium/Potassium Ratio

    Measured sodium and potassium in fasting, first-morning urine samples and analyzed in the Clinical Laboratory. Binary variable defined as urine sodium/potassium ratio >1 mmol/mmol. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Baseline through 2 years

  85. Low Estimated Glomerular Filtration Rate

    Estimated using validated, non-race-based, age-appropriate equations (modified Schwartz equation and height- and age-based full-age-spectrum equations with serum creatinine (analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry) and serum cystatin C (analyzed via the Clinical Laboratory). Defined as <90 ml/min/1.73 m^2. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).

    Measured: Through study completion up to 2 years

  86. Baseline Urine Uric Acid/Creatinine Ratio

    Measured in fasting first-morning urine samples. Uric acid quantified by well-validated uricase assay and creatinine via 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 percentile confidence interval).

    Measured: Baseline

  87. Change in Urine Uric Acid/Creatinine Ratio

    Measured in fasting first-morning urine samples. Uric acid quantified by well-validated uricase assay and creatinine via 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 percentile confidence interval).

    Measured: Baseline through 2 years

  88. Baseline Urine Uric Acid Per Glomerular Filtration Rate

    Measured in fasting first-morning urine and serum samples. Uric acid quantified by well-validated uricase assay and creatinine via modified Jaffe assay traceable to isotope dilution mass spectrometry. Calculated as [urine uric acid x serum creatinine] / [urine creatinine]. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).

    Measured: Baseline

  89. Change in Urine Uric Acid Per Glomerular Filtration Rate

    Measured in fasting first-morning urine and serum samples. Uric acid quantified by well-validated uricase assay and creatinine via modified Jaffe assay traceable to isotope dilution mass spectrometry. Calculated as [urine uric acid x serum creatinine] / [urine creatinine]. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).

    Measured: Baseline through 2 years

  90. Baseline Fractional Excretion of Urine Uric Acid

    Measured in fasting first-morning urine and serum samples. Uric acid quantified by well-validated uricase assay and creatinine via modified Jaffe assay traceable to isotope dilution mass spectrometry. Calculated as [urine uric acid x serum creatinine] / [urine creatinine x serum uric acid]. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).

    Measured: Baseline

  91. Change in Fractional Excretion of Urine Uric Acid

    Measured in fasting first-morning urine and serum samples. Uric acid quantified by well-validated uricase assay and creatinine via modified Jaffe assay traceable to isotope dilution mass spectrometry. Calculated as [urine uric acid x serum creatinine] / [urine creatinine x serum uric acid]. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).

    Measured: Baseline through 2 years

  92. Baseline Serum Fibroblast Growth Factor 23 Level

    Quantified in serum using a validated ELISA. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).

    Measured: Baseline

  93. Change in Serum Fibroblast Growth Factor 23 Level

    Quantified in serum using a validated ELISA. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).

    Measured: Baseline through 2 years

  94. Baseline Urine Fibroblast Growth Factor 23 Level

    Quantified in first-morning urine using a validated ELISA, 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 percentile confidence interval).

    Measured: Baseline

  95. Change in Urine Fibroblast Growth Factor 23 Level

    Quantified in first-morning urine using a validated ELISA, 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 percentile confidence interval).

    Measured: Baseline through 2 years

  96. Baseline Obesity

    Height and weight measured in triplicate and average value recorded. Body mass index calculated and obesity defined per national guidelines as body mass index ≥95th percentile for age and sex or ≥30.0 kg/m^2. Report relative measures (e.g., risk ratio, odds ratio) with measures of dispersion (e.g., 95 percentile confidence interval).

    Measured: Baseline

  97. Baseline Dietary Sodium Intake

    Estimated dietary sodium intake from self-administered food frequency questionnaire. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval)

    Measured: Baseline

  98. Baseline Disordered Eating

    5-item SCOFF questionnaire. Positive if participant answers yes to 2 or more of the 5 questions. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percentile confidence interval).

    Measured: Baseline

  99. Change in Disordered Eating

    5-item SCOFF questionnaire. Positive if participant answers yes to 2 or more of the 5 questions. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percentile confidence interval).

    Measured: Baseline through 2 years

  100. Baseline Financial Stress

    Assessed with a validated questionnaire consisting of one question measured on a 5-point ordinal scale: 1) not hard at all; 2) not very hard; 3) somewhat hard; 4) hard; 5) very hard. Positive if participant reports somewhat hard, hard, or very hard. Report relative measures (e.g., risk ratio, odds ratio) with measures of dispersion (e.g., 95 percentile confidence interval).

    Measured: Baseline

  101. Change in Financial Stress

    Assessed with a validated questionnaire consisting of one question measured on a 5-point ordinal scale: 1) not hard at all; 2) not very hard; 3) somewhat hard; 4) hard; 5) very hard. Positive if participant reports somewhat hard, hard, or very hard. Report relative measures (e.g., risk ratio, odds ratio) with measures of dispersion (e.g., 95 percentile confidence interval).

    Measured: Baseline through 2 years

  102. Baseline Food Insecurity

    Assessed with a validated questionnaire consisting of two questions both scored on a 3-point ordinal scale: 1) never true; 2) sometimes true; 3) often true. Positive if participant reports somewhat true or often true to either question. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percentile confidence interval).

    Measured: Baseline

  103. Change in Food Insecurity

    Assessed with a validated questionnaire consisting of two questions both scored on a 3-point ordinal scale: 1) never true; 2) sometimes true; 3) often true. Positive if participant reports somewhat true or often true to either question. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percentile confidence interval).

    Measured: Baseline through 2 years

  104. Baseline Transportation Stress

    Assessed with a validated questionnaire consisting of two binary questions. Positive if participant reports yes to either question. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percentile confidence interval).

    Measured: Baseline

  105. Change in Transportation Stress

    Assessed with a validated questionnaire consisting of two binary questions. Positive if participant reports yes to either question. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percentile confidence interval).

    Measured: Baseline through 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study start19 May 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04752293
Sponsor's protocol ID
IRB00068679
Other IDs
1K23HL148394-01A1
Acronym
PHRASE
Status last verified
Dec 2025
First submitted
21 Jan 2021
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after de-identification, will be shared with other researchers.

Publications

  • Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.

    PubMed 29386200

  • Laslett LJ, Alagona P Jr, Clark BA 3rd, Drozda JP Jr, Saldivar F, Wilson SR, Poe C, Hart M. The worldwide environment of cardiovascular disease: prevalence, diagnosis, therapy, and policy issues: a report from the American College of Cardiology. J Am Coll Cardiol. 2012 Dec 25;60(25 Suppl):S1-49. doi: 10.1016/j.jacc.2012.11.002.

    PubMed 23257320

  • Danaei G, Ding EL, Mozaffarian D, Taylor B, Rehm J, Murray CJ, Ezzati M. The preventable causes of death in the United States: comparative risk assessment of dietary, lifestyle, and metabolic risk factors. PLoS Med. 2009 Apr 28;6(4):e1000058. doi: 10.1371/journal.pmed.1000058. Epub 2009 Apr 28.

    PubMed 19399161

  • Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, Amann M, Anderson HR, Andrews KG, Aryee M, Atkinson C, Bacchus LJ, Bahalim AN, Balakrishnan K, Balmes J, Barker-Collo S, Baxter A, Bell ML, Blore JD, Blyth F, Bonner C, Borges G, Bourne R, Boussinesq M, Brauer M, Brooks P, Bruce NG, Brunekreef B, Bryan-Hancock C, Bucello C, Buchbinder R, Bull F, Burnett RT, Byers TE, Calabria B, Carapetis J, Carnahan E, Chafe Z, Charlson F, Chen H, Chen JS, Cheng AT, Child JC, Cohen A, Colson KE, Cowie BC, Darby S, Darling S, Davis A, Degenhardt L, Dentener F, Des Jarlais DC, Devries K, Dherani M, Ding EL, Dorsey ER, Driscoll T, Edmond K, Ali SE, Engell RE, Erwin PJ, Fahimi S, Falder G, Farzadfar F, Ferrari A, Finucane MM, Flaxman S, Fowkes FG, Freedman G, Freeman MK, Gakidou E, Ghosh S, Giovannucci E, Gmel G, Graham K, Grainger R, Grant B, Gunnell D, Gutierrez HR, Hall W, Hoek HW, Hogan A, Hosgood HD 3rd, Hoy D, Hu H, Hubbell BJ, Hutchings SJ, Ibeanusi SE, Jacklyn GL, Jasrasaria R, Jonas JB, Kan H, Kanis JA, Kassebaum N, Kawakami N, Khang YH, Khatibzadeh S, Khoo JP, Kok C, Laden F, Lalloo R, Lan Q, Lathlean T, Leasher JL, Leigh J, Li Y, Lin JK, Lipshultz SE, London S, Lozano R, Lu Y, Mak J, Malekzadeh R, Mallinger L, Marcenes W, March L, Marks R, Martin R, McGale P, McGrath J, Mehta S, Mensah GA, Merriman TR, Micha R, Michaud C, Mishra V, Mohd Hanafiah K, Mokdad AA, Morawska L, Mozaffarian D, Murphy T, Naghavi M, Neal B, Nelson PK, Nolla JM, Norman R, Olives C, Omer SB, Orchard J, Osborne R, Ostro B, Page A, Pandey KD, Parry CD, Passmore E, Patra J, Pearce N, Pelizzari PM, Petzold M, Phillips MR, Pope D, Pope CA 3rd, Powles J, Rao M, Razavi H, Rehfuess EA, Rehm JT, Ritz B, Rivara FP, Roberts T, Robinson C, Rodriguez-Portales JA, Romieu I, Room R, Rosenfeld LC, Roy A, Rushton L, Salomon JA, Sampson U, Sanchez-Riera L, Sanman E, Sapkota A, Seedat S, Shi P, Shield K, Shivakoti R, Singh GM, Sleet DA, Smith E, Smith KR, Stapelberg NJ, Steenland K, Stockl H, Stovner LJ, Straif K, Straney L, Thurston GD, Tran JH, Van Dingenen R, van Donkelaar A, Veerman JL, Vijayakumar L, Weintraub R, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams W, Wilson N, Woolf AD, Yip P, Zielinski JM, Lopez AD, Murray CJ, Ezzati M, AlMazroa MA, Memish ZA. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2224-60. doi: 10.1016/S0140-6736(12)61766-8.

    PubMed 23245609

  • Saran R, Li Y, Robinson B, Ayanian J, Balkrishnan R, Bragg-Gresham J, Chen JT, Cope E, Gipson D, He K, Herman W, Heung M, Hirth RA, Jacobsen SS, Kalantar-Zadeh K, Kovesdy CP, Leichtman AB, Lu Y, Molnar MZ, Morgenstern H, Nallamothu B, O'Hare AM, Pisoni R, Plattner B, Port FK, Rao P, Rhee CM, Schaubel DE, Selewski DT, Shahinian V, Sim JJ, Song P, Streja E, Kurella Tamura M, Tentori F, Eggers PW, Agodoa LY, Abbott KC. US Renal Data System 2014 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2015 Jul;66(1 Suppl 1):Svii, S1-305. doi: 10.1053/j.ajkd.2015.05.001. No abstract available.

    PubMed 26111994

  • Chen X, Wang Y. Tracking of blood pressure from childhood to adulthood: a systematic review and meta-regression analysis. Circulation. 2008 Jun 24;117(25):3171-80. doi: 10.1161/CIRCULATIONAHA.107.730366. Epub 2008 Jun 16.

    PubMed 18559702

  • Hao G, Wang X, Treiber FA, Harshfield G, Kapuku G, Su S. Blood Pressure Trajectories From Childhood to Young Adulthood Associated With Cardiovascular Risk: Results From the 23-Year Longitudinal Georgia Stress and Heart Study. Hypertension. 2017 Mar;69(3):435-442. doi: 10.1161/HYPERTENSIONAHA.116.08312. Epub 2017 Jan 16.

    PubMed 28093467

  • Flynn JT, Kaelber DC, Baker-Smith CM, et al; SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017; 140(3):e20171904. Pediatrics. 2017 Dec;140(6):e20173035. doi: 10.1542/peds.2017-3035. No abstract available.

    PubMed 29192011

  • Din-Dzietham R, Liu Y, Bielo MV, Shamsa F. High blood pressure trends in children and adolescents in national surveys, 1963 to 2002. Circulation. 2007 Sep 25;116(13):1488-96. doi: 10.1161/CIRCULATIONAHA.106.683243. Epub 2007 Sep 10.

    PubMed 17846287

  • Assadi F. Effect of microalbuminuria lowering on regression of left ventricular hypertrophy in children and adolescents with essential hypertension. Pediatr Cardiol. 2007 Jan-Feb;28(1):27-33. doi: 10.1007/s00246-006-1390-4. Epub 2007 Feb 16.

    PubMed 17308944

  • Litwin M, Niemirska A, Sladowska-Kozlowska J, Wierzbicka A, Janas R, Wawer ZT, Wisniewski A, Feber J. Regression of target organ damage in children and adolescents with primary hypertension. Pediatr Nephrol. 2010 Dec;25(12):2489-99. doi: 10.1007/s00467-010-1626-7. Epub 2010 Aug 21.

    PubMed 20730452

  • Seeman T, Dostalek L, Gilik J. Control of hypertension in treated children and its association with target organ damage. Am J Hypertens. 2012 Mar;25(3):389-95. doi: 10.1038/ajh.2011.218. Epub 2011 Nov 17.

    PubMed 22089110

  • Samuel JP, Samuels JA, Brooks LE, Bell CS, Pedroza C, Molony DA, Tyson JE. Comparative effectiveness of antihypertensive treatment for older children with primary hypertension: study protocol for a series of n-of-1 randomized trials. Trials. 2016 Jan 8;17:16. doi: 10.1186/s13063-015-1142-y.

    PubMed 26746195

  • Benjamin DK Jr, Smith PB, Jadhav P, Gobburu JV, Murphy MD, Hasselblad V, Baker-Smith C, Califf RM, Li JS. Pediatric antihypertensive trial failures: analysis of end points and dose range. Hypertension. 2008 Apr;51(4):834-40. doi: 10.1161/HYPERTENSIONAHA.107.108886. Epub 2008 Mar 10.

    PubMed 18332283

  • Feber J, Ahmed M. Hypertension in children: new trends and challenges. Clin Sci (Lond). 2010 May 14;119(4):151-61. doi: 10.1042/CS20090544.

    PubMed 20477751

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Left Ventricular Hypertrophy, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrew M South, MD, MS (336.716.9640, asouth@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Urine Angiotensin-(1-7)/Creatinine Ratio (time frame: Baseline). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04752293, which also lists 92 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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