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Recruiting NCT04026776

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

Early Phase I Interventional Salt; Excess Blood Pressure Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Allopurinol, Dietary Intervention.
Who it may be relevant to
Registry conditions: Salt; Excess, Blood Pressure Disorders. Basic parameters: 22 years — 33 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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.

Interventions

  • Drug Allopurinol
    Study Part 2- Preterm group only: After Visit 5 preterm born participants will start allopurinol 200 mg daily PO for 6 weeks. The 1 week high and low salt diets and assessments will be repeated while on allopurinol.
  • 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 Clinical Research Unit Metabolic Kitchen. Part 2 preterm only- the diets will be repeated while the participant is taking allopurinol.

Primary outcome measures

  • Proportion with salt sensitivity of blood pressure at baseline via ABPM [Time frame: Day 7 to 14]
  • Proportion with salt sensitivity of blood pressure after allopurinol via ABPM [Time frame: Day 49 to 56]
  • Salt sensitivity index at baseline [Time frame: Day 7 to 14]
  • Salt sensitivity index after allopurinol [Time frame: Day 49 to 56]
  • Proportion with salt sensitivity of blood pressure at baseline via casual blood pressure [Time frame: Day 7 to 14]
  • Proportion with salt sensitivity of blood pressure after allopurinol via casual blood pressure [Time frame: Day 49 to 56]
  • High blood pressure at baseline via ABPM [Time frame: Day 0]
  • Hypertension at baseline via ABPM [Time frame: Day 7]
  • High blood pressure at baseline via casual blood pressure [Time frame: First 3 study visits]
  • Hypertension at baseline via casual blood pressure [Time frame: First 3 study visits]
Secondary outcome measures (12)
  • Ambulatory systolic blood pressure 24-hour mean at baseline [Time frame: Day 0]
  • Ambulatory diastolic blood pressure 24-hour mean at baseline [Time frame: Day 0]
  • Ambulatory mean arterial pressure 24-hour mean at baseline [Time frame: Day 0]
  • Ambulatory systolic blood pressure awake mean at baseline [Time frame: Day 0]
  • Ambulatory diastolic blood pressure awake mean at baseline [Time frame: Day 0]
  • Ambulatory mean arterial pressure awake mean at baseline [Time frame: Day 0]
  • Ambulatory systolic blood pressure asleep mean at baseline [Time frame: Day 0]
  • Ambulatory diastolic blood pressure asleep mean at baseline [Time frame: Day 0]
  • Ambulatory mean arterial pressure asleep mean at baseline [Time frame: Day 0]
  • Ambulatory systolic blood pressure 24-hour load at baseline [Time frame: Day 0]
  • Ambulatory diastolic blood pressure 24-hour load at baseline [Time frame: Day 0]
  • Ambulatory systolic blood pressure awake load at baseline [Time frame: Day 0]

Eligibility criteria

Inclusion criteria

  • Singleton birth
  • Born at less than 34 weeks gestational age (preterm cohort)
  • Born at greater than 36 weeks gestational age (term cohort)

Exclusion criteria

  • Twin birth
  • Congenital anomalies or genetic syndromes
  • Currently pregnant or breast feeding
  • Subject-reported history of hypertension
  • Current use of antihypertensive medications
  • Active cancer
  • Chronic kidney disease
  • Heart failure
  • Liver failure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT04026776 · IRB00057527 · 1R01HL146818-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗