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

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)

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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