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Uric Acid, Klotho and Salt Sensitivity in Young Adults Born Preterm (PEPC3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04026776
Recruitment Status : Suspended (COVID19)
First Posted : July 19, 2019
Last Update Posted : June 3, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
The purpose of this research is to learn about how salt in the diet influences blood pressure in young adults who were born prematurely.

Condition or disease Intervention/treatment Phase
Salt; Excess Blood Pressure Disorders Drug: Allopurinol Other: Dietary Intervention Early Phase 1

Detailed Description:
Premature birth is an emerging and important risk factor for hypertension and cardiovascular disease, as both preterm birth rates and infant survival increase worldwide. Hypertension and cardiovascular disease begin in early adulthood in individuals born prematurely, but the reasons especially in regard to the role of preterm birth are unknown. An improved understanding of why hypertension and cardiovascular disease occur in early adulthood in individuals born preterm will enable the development of prevention and treatment strategies to mitigate the burden of cardiovascular disease. Investigators propose to investigate these relationships mechanistically in a clinical trial of subjects born preterm to establish the SSBP (salt sensitivity of blood pressure) phenotype and study its relationship to CVD (cardiovascular disease) compared to a control group of healthy term- born peers. Investigators will then propose to determine if blocking UA (uric acid) formation improves SSBP and cardiovascular function in subjects born preterm.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Uric Acid, Klotho and Salt Sensitivity in Young Adults Born Preterm
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Sodium

Arm Intervention/treatment
Experimental: Preterm Group
Subjects with very low birth weight (<37 completed weeks' gestation and birth weight <1500 g) at a regional perinatal center will receive a dietary intervention (high/low salt diet) and FDA approved drug, Allopurinol
Drug: Allopurinol
At Visit 3 preterm birth subjects will start the standard-Na+ diet for 7 weeks and after 1 week will start allopurinol 200 mg daily PO for 8 weeks.

Other: Dietary Intervention
High-Na+ (250 mmol/d) and low-Na+ (50 mmol/d) standard isocaloric K+ diets (75 mmol/1000 kcal/d) for 1 week each as 3 meals and 1 snack a day provided by the CRU Metabolic Kitchen.Self-provided intake phase: Subjects will be counseled by the RD (Registered Dietitian) to consume a standard-Na+, isocaloric diet (150 mmol Na+ and 40 mmol/1000 kcal K+ daily) for 7 weeks.

Active Comparator: Term-born control group
Subjects with birth weight ≥2500 g will receive a dietary intervention (high/low salt diet)
Other: Dietary Intervention
High-Na+ (250 mmol/d) and low-Na+ (50 mmol/d) standard isocaloric K+ diets (75 mmol/1000 kcal/d) for 1 week each as 3 meals and 1 snack a day provided by the CRU Metabolic Kitchen.Self-provided intake phase: Subjects will be counseled by the RD (Registered Dietitian) to consume a standard-Na+, isocaloric diet (150 mmol Na+ and 40 mmol/1000 kcal K+ daily) for 7 weeks.




Primary Outcome Measures :
  1. Proportion with salt sensitivity of blood pressure at baseline via ABPM [ Time Frame: Day 7 to 14 ]
    Defined as a ≥8 mmHg decrease in mean arterial blood pressure when moving from the high-Na+ to the low-Na+ phase, as measured on 24-hour ambulatory blood pressure monitoring (ABPM).

  2. Proportion with salt sensitivity of blood pressure after allopurinol via ABPM [ Time Frame: Day 49 to 56 ]
    A ≥8 mmHg decrease in mean arterial blood pressure when moving from the high-Na+ to the low-Na+ phase while taking allopurinol, as measured on 24-hour ambulatory blood pressure monitoring (ABPM).

  3. Salt sensitivity index at baseline [ Time Frame: Day 7 to 14 ]
    The ratio between the change in 24-hour mean arterial pressure, as measured on 24-hour ambulatory blood pressure monitoring, and the change in 24-hour urine Na+ concentration when moving from the high-Na+ phase to the low-Na+ phase.

  4. Salt sensitivity index after allopurinol [ Time Frame: Day 49 to 56 ]
    The ratio between the change in 24-hour mean arterial pressure, as measured on 24-hour ambulatory blood pressure monitoring, and the change in 24-hour urine Na+ concentration when moving from the high-Na+ phase to the low-Na+ phase while taking allopurinol

  5. Proportion with salt sensitivity of blood pressure at baseline via casual blood pressure [ Time Frame: Day 7 to 14 ]
    A >=5 mmHg decrease in mean arterial blood pressure measured in clinic when moving from the high-Na+ phase to the low-Na+ phase. Casual blood pressure measured 3 consecutive times via auscultation with the average of the 3 mean arterial blood pressure measurements recorded.

  6. Proportion with salt sensitivity of blood pressure after allopurinol via casual blood pressure [ Time Frame: Day 49 to 56 ]
    A >=5 mmHg decrease in mean arterial blood pressure measured in clinic when moving from the high-Na+ phase to the low-Na+ phase while taking allopurinol. Casual blood pressure measured 3 consecutive times via auscultation with the average of the 3 mean arterial blood pressure measurements recorded.

  7. High blood pressure at baseline via ABPM [ Time Frame: Day 0 ]
    Proportion with 24-hour mean systolic or diastolic blood pressure ≥115/75 mmHg, awake mean systolic or diastolic blood pressure ≥120/80 mmHg, or asleep mean systolic or diastolic blood pressure ≥100/65 mmHg, measured with ambulatory blood pressure monitoring (ABPM).

  8. Hypertension at baseline via ABPM [ Time Frame: Day 7 ]
    Proportion with 24-hour mean systolic or diastolic blood pressure ≥125/75 mmHg, awake mean systolic or diastolic blood pressure ≥130/80 mmHg, or asleep mean systolic or diastolic blood pressure ≥110/65 mmHg, measured with ambulatory blood pressure monitoring (ABPM).

  9. High blood pressure at baseline via casual blood pressure [ Time Frame: First 3 study visits ]
    Proportion with mean systolic or diastolic blood pressure ≥120/80 mmHg, measured via 3 consecutive auscultated measurements (averaged) at each of 3 separate study visits.

  10. Hypertension at baseline via casual blood pressure [ Time Frame: First 3 study visits ]
    Proportion with mean systolic or diastolic blood pressure ≥130/80 mmHg, measured via 3 consecutive auscultated measurements (averaged) at each of 3 separate study visits

  11. Serum uric acid at baseline [ Time Frame: Day 0 ]
    Serum uric acid concentration at baseline

  12. Change in serum uric acid with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in serum uric acid levels when moving from high-Na+ phase to the low-Na+ phase

  13. Change in serum uric acid with dietary Na+ intervention on allopurinol [ Time Frame: Day 42 to 56 ]
    The change in serum uric acid levels when moving from high-Na+ phase to the low-Na+ phase while on allopurinol

  14. Pulse wave velocity at baseline [ Time Frame: Day 0 ]
    Carotid femoral pulse wave velocity will be measured at baseline with the SphygmoCor XCEL device

  15. Augmentation index at baseline [ Time Frame: Day 0 ]
    Augmentation index will be measured at baseline with the SphygmoCor XCEL device

  16. Heart rate variability at baseline [ Time Frame: Day 0 ]
    Heart rate variability will be measured at baseline using continuous heart rate recording using the CNAP™ Monitor 500i

  17. Baroreflex sensitivity at baseline [ Time Frame: Day 0 ]
    Baroreflex sensitivity will be measured at baseline using continuous blood pressure and heart rate using the CNAP™ Monitor 500i

  18. Angiotensin-(1-7) at baseline [ Time Frame: Day 0 ]
    Plasma angiotensin-(1-7) concentration and urine angiotensin-(1-7)/creatinine at baseline

  19. Angiotensin II at baseline [ Time Frame: Day 0 ]
    Plasma angiotensin II concentration and urine angiotensin II/creatinine at baseline

  20. Klotho at baseline [ Time Frame: Day 0 ]
    Plasma klotho concentration and urine klotho/creatinine at baseline.

  21. Creatinine at baseline [ Time Frame: Day 0 ]
    Serum creatinine concentration at baseline

  22. Cystatin C at baseline [ Time Frame: Day 0 ]
    Serum cystatin C concentration at baseline

  23. eGFR at baseline [ Time Frame: Day 0 ]
    Estimated glomerular filtration rate (eGFR) at baseline.We will calculate the eGFR by the CKD-EPI Creatinine-Cystatin C 2012 equation and by 24 hour creatinine


Secondary Outcome Measures :
  1. Ambulatory systolic blood pressure 24-hour mean at baseline [ Time Frame: Day 0 ]
    Average systolic blood pressure over 24 hours, measured with ambulatory blood pressure monitors

  2. Ambulatory diastolic blood pressure 24-hour mean at baseline [ Time Frame: Day 0 ]
    Average diastolic blood pressure over 24 hours, measured with ambulatory blood pressure monitors

  3. Ambulatory mean arterial pressure 24-hour mean at baseline [ Time Frame: Day 0 ]
    Average mean arterial pressure over 24 hours, measured with ambulatory blood pressure monitors

  4. Ambulatory systolic blood pressure awake mean at baseline [ Time Frame: Day 0 ]
    Average systolic blood pressure while awake, measured with ambulatory blood pressure monitors

  5. Ambulatory diastolic blood pressure awake mean at baseline [ Time Frame: Day 0 ]
    Average diastolic blood pressure while awake, measured with ambulatory blood pressure monitors

  6. Ambulatory mean arterial pressure awake mean at baseline [ Time Frame: Day 0 ]
    Average mean arterial pressure while awake, measured with ambulatory blood pressure monitors

  7. Ambulatory systolic blood pressure asleep mean at baseline [ Time Frame: Day 0 ]
    Average systolic blood pressure while asleep, measured with ambulatory blood pressure monitors

  8. Ambulatory diastolic blood pressure asleep mean at baseline [ Time Frame: Day 0 ]
    Average diastolic blood pressure while asleep, measured with ambulatory blood pressure monitors

  9. Ambulatory mean arterial pressure asleep mean at baseline [ Time Frame: Day 0 ]
    Average mean arterial pressure while asleep, measured with ambulatory blood pressure monitors

  10. Ambulatory systolic blood pressure 24-hour load at baseline [ Time Frame: Day 0 ]
    Proportion of mean 24-hour systolic blood pressures ≥125 mmHg, measured with ambulatory blood pressure monitors

  11. Ambulatory diastolic blood pressure 24-hour load at baseline [ Time Frame: Day 0 ]
    Proportion of mean 24-hour diastolic blood pressures ≥75 mmHg, measured with ambulatory blood pressure monitors.

  12. Ambulatory systolic blood pressure awake load at baseline [ Time Frame: Day 0 ]
    Proportion of mean awake systolic blood pressures ≥130 mmHg, measured with ambulatory blood pressure monitors

  13. Ambulatory diastolic blood pressure awake load at baseline [ Time Frame: Day 0 ]
    Proportion of mean awake diastolic blood pressures ≥80 mmHg, measured with ambulatory blood pressure monitors

  14. Ambulatory systolic blood pressure asleep load at baseline [ Time Frame: Day 0 ]
    Proportion of mean asleep systolic blood pressures ≥110 mmHg, measured with ambulatory blood pressure monitors

  15. Ambulatory diastolic blood pressure asleep load at baseline [ Time Frame: Day 0 ]
    Proportion of mean asleep diastolic blood pressures ≥65 mmHg, measured with ambulatory blood pressure monitors

  16. Ambulatory systolic blood pressure nocturnal dipping at baseline [ Time Frame: Day 0 ]
    Percent change in mean awake to mean asleep systolic blood pressure, measured with ambulatory blood pressure monitors

  17. Ambulatory diastolic blood pressure nocturnal dipping at baseline [ Time Frame: Day 0 ]
    Percent change in mean awake to mean asleep diastolic blood pressure, measured with ambulatory blood pressure monitors

  18. Casual systolic blood pressure at baseline [ Time Frame: Day 0 ]
    Measured 3 consecutive times via auscultation with the average of the 3 systolic blood pressure measurements recorded

  19. Casual diastolic blood pressure at baseline [ Time Frame: Day 0 ]
    Measured 3 consecutive times via auscultation with the average of the 3 diastolic blood pressure measurements recorded

  20. Change in pulse wave velocity with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in carotid femoral pulse wave velocity will be measured with the SphygmoCor XCEL device when moving from high-Na+ phase to the low-Na+ phase

  21. Change in augmentation index with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in augmentation index will be measured with the SphygmoCor XCEL device when moving from high-Na+ phase to the low-Na+ phase

  22. Change in pulse wave velocity with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in carotid femoral pulse wave velocity will be measured with the SphygmoCor XCEL device when moving from high-Na+ phase to the low-Na+ phase while on allopurinol.

  23. Change in augmentation index with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in augmentation index will be measured with the SphygmoCor XCEL device when moving from high-Na+ phase to the low-Na+ phase while on allopurinol

  24. Change in heart rate variability with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in heart rate variability will be measured using the CNAP™ Monitor 500i when moving from high-Na+ phase to the low-Na+ phase

  25. Change in baroreflex sensitivity with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in baroreflex sensitivity will be measured using the CNAP™ Monitor 500i when moving from high-Na+ phase to the low-Na+ phase

  26. Change in heart rate variability with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in heart rate variability will be measured using the CNAP™ Monitor 500i when moving from high-Na+ phase to the low-Na+ phase while on allopurinol

  27. Change in baroreflex sensitivity with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in baroreflex sensitivity will be measured using the CNAP™ Monitor 500i when moving from high-Na+ phase to the low-Na+ phase while on allopurinol

  28. Change in angiotensin-(1-7) with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in plasma angiotensin-(1-7) concentration and urine angiotensin-(1-7)/creatinine when moving from the high-Na+ phase to the low-Na+ phase

  29. Change in angiotensin II with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in plasma angiotensin II concentration and urine angiotensin II/creatinine when moving from the high-Na+ phase to the low-Na+ phase

  30. Change in klotho with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in plasma klotho concentration and urine klotho/creatinine when moving from the high-Na+ phase to the low-Na+ phase

  31. Change in angiotensin-(1-7) with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in plasma angiotensin-(1-7) concentration and urine angiotensin-(1-7)/creatinine when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol

  32. Change in angiotensin II with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in plasma angiotensin II concentration and urine angiotensin II/creatinine when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol

  33. Change in klotho with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in plasma klotho concentration and urine klotho/creatinine when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol

  34. ACE2 at baseline [ Time Frame: Day 0 ]
    Serum ACE2 concentration and activity and urine ACE2/creatinine and activity at baseline

  35. ACE at baseline [ Time Frame: Day 0 ]
    Serum ACE concentration and activity and urine ACE/creatinine and activity at baseline

  36. FGF23 at baseline [ Time Frame: Day 0 ]
    Plasma fibroblast growth factor 23 (FGF23) concentration and urine FGF23/creatinine at baseline

  37. Change in ACE2 with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in serum ACE2 concentration and activity and urine ACE2/creatinine and activity when moving from the high-Na+ phase to the low-Na+ phase

  38. Change in ACE2 with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in serum ACE2 concentration and activity and urine ACE2/creatinine and activity when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol

  39. Change in ACE with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in serum ACE concentration and activity and urine ACE2/creatinine and activity when moving from the high-Na+ phase to the low-Na+ phase

  40. Change in ACE with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in serum ACE concentration and activity and urine ACE2/creatinine and activity when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol

  41. Change in FGF23 with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in serum fibroblast growth factor 23 (FGF23) concentration and urine FGF23/creatinine when moving from the high-Na+ phase to the low-Na+ phase

  42. Change in FGF23 with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in serum fibroblast growth factor 23 (FGF23) concentration and urine FGF23/creatinine when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol

  43. Neprilysin level at baseline [ Time Frame: Day 0 ]
    Serum neprilysin concentration and activity and urine neprilysin/creatinine and activity at baseline

  44. Change in neprilysin with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in serum neprilysin concentration and activity and urine neprilysin/creatinine and activity when moving from the high-Na+ phase to the low-Na+ phase

  45. Change in neprilysin with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in serum neprilysin concentration and activity and urine neprilysin/creatinine and activity when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol

  46. Urine albumin at baseline [ Time Frame: Day 0 ]
    Urine albumin/creatinine at baseline on first-morning urine sample

  47. Proportion with albuminuria [ Time Frame: Day 0 ]
    Albuminuria at baseline, defined as urine albumin/creatinine >30 mg/g on first-morning urine sample

  48. Urine protein at baseline [ Time Frame: Day 0 ]
    Urine protein/creatinine at baseline on first-morning urine sample

  49. Proportion with proteinuria [ Time Frame: Day 0 ]
    Proteinuria at baseline, defined as urine protein/creatinine >0.2 mg/mg on first-morning urine sample

  50. Angiotensinogen at baseline [ Time Frame: Day 0 ]
    Serum angiotensinogen concentration and urine angiotensinogen/creatinine at baseline

  51. Change in angiotensinogen with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in serum angiotensinogen concentration and urine angiotensinogen/creatinine when moving from the high-Na+ phase to the low-Na+ phase

  52. Change in angiotensinogen with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in serum angiotensinogen concentration and urine angiotensinogen/creatinine when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol

  53. 24-hour sodium excretion at baseline [ Time Frame: Day 0 ]
    Sodium excretion in the urine over 24 hours at baseline

  54. 24-hour potassium excretion at baseline [ Time Frame: Day 0 ]
    Potassium excretion in the urine over 24 hours at baseline

  55. 24-hour uric acid excretion at baseline [ Time Frame: Day 0 ]
    Uric acid excretion in the urine over 24 hours at baseline

  56. Pulse wave velocity (CF) at baseline [ Time Frame: Day 0 ]
    Carotid-femoral (CF) pulse wave velocity will be measured at baseline with the SphygmoCor XCEL device

  57. Change in pulse wave velocity (CF) with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in carotid-femoral (CF) pulse wave velocity will be measured with the SphygmoCor XCEL device when moving from high-Na+ phase to the low-Na+ phase

  58. Change in pulse wave velocity (CF) with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in carotid-femoral (CF) pulse wave velocity will be measured with the SphygmoCor XCEL device when moving from high-Na+ phase to the low-Na+ phase while on allopurinol

  59. Angiotensin II:angiotensin-(1-7) at baseline [ Time Frame: Day 0 ]
    Plasma and urine angiotensin II:angiotensin-(1-7) at baseline

  60. Change in angiotensin II:angiotensin-(1-7) with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in plasma angiotensin II:angiotensin-(1-7) when moving from the high-Na+ phase to the low-Na+ phase

  61. Change in angiotensin II:angiotensin-(1-7) with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in plasma angiotensin II:angiotensin-(1-7) when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol

  62. ACE:ACE2 at baseline [ Time Frame: Day 0 ]
    Serum and urine ACE:ACE2 at baseline

  63. Change in ACE:ACE2 with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
    The change in serum and urine ACE:ACE2 when moving from the high-Na+ phase to the low-Na+ phase

  64. Change in ACE:ACE2 with dietary Na+ intervention while on allopurinol [ Time Frame: Day 49 to 56 ]
    The change in serum and urine ACE:ACE2 when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol

  65. Body mass index at baseline [ Time Frame: Day 0 ]
    Body mass index at baseline

  66. Proportion with overweight/obesity [ Time Frame: Day 0 ]
    Overweight/obesity at baseline, defined as a body mass index >=25 kg/m2

  67. Proportion with obesity [ Time Frame: Day 0 ]
    Obesity at baseline, defined as a body mass index >=30 kg/m2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   24 Years to 33 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 24 - 33 years old
  • Single birth
  • Born at Forsyth Medical Center in Winston Salem, NC and follow-up data at 1 year of age (preterm cohort)

Exclusion Criteria:

  • Twin birth
  • Congenital anomalies or genetic syndromes
  • Exposure to antenatal steroids(term cohort)
  • Currently pregnant or breast feeding
  • Subject-reported history of hypertension
  • Current use of antihypertensive medications
  • Active cancer
  • Chronic kidney disease
  • Heart failure
  • Liver failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026776


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Lisa Washburn, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04026776    
Other Study ID Numbers: IRB00057527
1R01HL146818-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: June 3, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD that underlie the results reported in this record, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Begining 3 months and ending 5 years following publication.
Access Criteria: Proposals should be directed to liwashbu@wakehealth.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
Uric Acid sensitivity
Salt sensitivity
Blood Pressure Influences
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs