Clinical Trials Directory

Trials / Completed

CompletedNCT02730780

The Natriuretic Peptide System in African-Americans.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Vanderbilt University · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

This study aims to assess the natriuretic peptide response to dietary salt loading in African-American individuals compared with white individuals.

Detailed description

High blood pressure, or hypertension, is a major cause of heart disease, heart failure, and stroke. Natriuretic peptides are cardiac derived hormones that may protect against hypertension. The classical actions of the natriuretic peptides include natriuresis, vasodilation, and inhibition of the renin-angiotensin-aldosterone system (RAAS), which support a key role for these hormones in blood pressure regulation. Race based differences exist in the risk and severity of hypertension and cardiovascular disease, with African-American individuals typically being at greater risk compared with white individuals. Nearly half of African-American adults have hypertension, compared with one-third of whites. Additionally, salt-sensitivity denotes the impaired ability to handle a salt load with resulting increases in blood pressure. It is estimated that 75% of hypertensive African-Americans exhibit salt-sensitivity, compared with 35% of hypertensive whites. Why this predilection towards salt-sensitivity exists, particularly among African-American individuals, is not well understood. Thus, establishing the origins of salt retention in African Americans has biologic, preventative, and therapeutic importance, and may provide insight regarding racial differences in cardiovascular risk. The natriuretic peptide system is the principal counter-regulatory mechanism to salt retention. However, little is known regarding racial differences in the natriuretic peptide system. Recently, it was discovered that African-Americans have lower natriuretic peptide levels compared with whites, raising the possibility that African-Americans individuals can have a relative "natriuretic peptide deficiency" with reduced natriuretic peptide responses to salt loading. However, the prior studies were based on epidemiologic data with individuals on random salt backgrounds. This highlights the need for more detailed physiologic studies, under controlled salt conditions and with standardized assessment of the natriuretic peptide and RAAS and tissue sodium stores. The aim of this study is to assess the natriuretic peptide response to dietary salt loading in African-American individuals compared with white individuals. This study will test the primary hypothesis that compared with whites, African-American individuals have blunted natriuretic peptide responses to dietary salt loading. Secondary hypotheses include: 1. Compared with white individuals, African-American individuals have higher baseline tissue sodium content, and 2. Compared with white individuals, African-American individuals have impaired "target organ" responses to salt loading, as manifested by higher blood pressure and increased frequency of salt-sensitive hypertension, decreased urinary sodium excretion, less suppression of plasma renin and serum aldosterone, and lack of increase in left ventricular early diastolic relaxation velocities.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTLow-Salt DietThe low-salt diet (7 days) will consist of meals, snacks, and sodium free water provided by the study staff.
DIETARY_SUPPLEMENTHigh-Salt DietThe high-salt diet (7 days) consists of each subject's usual diet, supplemented each day with 2 bouillon broth packets, which will be provided to the subject by the study staff.

Timeline

Start date
2016-07-22
Primary completion
2021-05-20
Completion
2021-05-20
First posted
2016-04-06
Last updated
2022-11-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02730780. Inclusion in this directory is not an endorsement.