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

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status and phase

Enrolling
Early Phase 1

Conditions

Blood Pressure Disorders
Salt; Excess

Treatments

Other: Dietary Intervention
Drug: Allopurinol

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04026776
IRB00057527
1R01HL146818-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

165 estimated patients

Sex

All

Ages

24 to 32 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Born 1990-1998
  • 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

165 participants in 2 patient groups

Preterm Group
Experimental group
Description:
Subjects with very low birth weight (\<37 completed weeks' gestation and birth weight \<1500 g) will receive a dietary intervention (high/low salt diet) and FDA approved drug, Allopurinol
Treatment:
Drug: Allopurinol
Other: Dietary Intervention
Term-born control group
Active Comparator group
Description:
Subjects with birth weight ≥2500 g will receive a dietary intervention (high/low salt diet)
Treatment:
Other: Dietary Intervention

Trial contacts and locations

1

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Central trial contact

Hossam Shaltout, PhD

Data sourced from clinicaltrials.gov

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