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NCT04258332 · ClinicalTrials.gov registry record · NA
CARDIA-Salt Sensitivity of Blood Pressure (SSBP)
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 281
- Enrollment target
NCT04258332: Completed NA study, sponsored by Vanderbilt University Medical Center.
NCT04258332 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 281 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04258332, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 281 participants
- Enrollment target
Study Summary
Salt sensitivity of blood pressure (SSBP) is defined as the change in blood pressure (BP) in relation to change in salt intake. An increase in BP from low- to high-salt diet is common and associated with an increased risk of cardiovascular morbidity and mortality, even among normotensive individuals. Yet, the pathophysiology of SSBP is not well understood. The prevailing paradigm is that abnormalities of neurohormones that regulate sodium (Na+) retention and excretion and/or Na+ transporting pathways create Na+ imbalances that underlie susceptibility to SSBP. As a homeostatic mechanism, BP fluctuates to maintain Na+ balance, i.e. higher BP is needed for pressure natriuresis to excrete excess Na+. An alternate framework emphasizes vascular dysregulation as the inciting mechanism. In both constructs, how Na+ itself influences BP remains incompletely understood. Our preliminary work suggests that excess Na+ induces a pro-inflammatory state that sustains higher BP. Interleukin-6 (IL-6) drives the induction of interleukin-17 (IL-17) secreting T helper 17 cells that were recently demonstrated to be pathogenic in response to Na+ exposure. IL-6, IL-17 and related cytokines regulate renal Na+ transporters and raise BP through vascular inflammation, fibrosis, and impaired vasodilation. The immune response to high- and low-salt diet in humans, however, is not completely understood, emphasizing the need for more detailed human studies, with deeper immune profiling under controlled salt conditions and with neurohormonal assessment. Our overarching postulate is that the inflammatory response to excess dietary salt intake is associated with SSBP. The Coronary Artery Risk Development in Young Adults (CARDIA) study is the ideal cohort in which to translate our preliminary findings. Investigators propose to investigate SSBP in CARDIA using standardized low- and high-salt diets and 24-hour ambulatory BP monitoring. Investigators will quantify SSBP in a total of 500 participants from t
Primary Outcome
The change in 24-hour ambulatory mean arterial pressure (MAP) following one week of high-salt and following one week of low-salt diet. This is calculated as the 24 hour ambulatory MAP on the high-salt diet minus the 24 hour ambulatory MAP on the low-salt diet.
Interventions
- DIETARY_SUPPLEMENT High Salt Diet
- DIETARY_SUPPLEMENT Low Salt Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 2021-05-17 |
| Est. Completion | 2025-05-17 |
| Phase | NA |
What the finished NCT04258332 record still lists
NCT04258332 is an interventional study that assigns participants to a tested intervention. The registered 281 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which High Salt Diet is the first listed.
NCT04258332 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04258332 about?
NCT04258332 is a clinical study titled "CARDIA-Salt Sensitivity of Blood Pressure (SSBP)". Salt sensitivity of blood pressure (SSBP) is defined as the change in blood pressure (BP) in relation to change in salt intake. An increase in BP from low- to high-salt diet is common and associated with an increased risk of cardiovascular morbidity and mortality, even among normotensive individuals...
What is the current status of trial NCT04258332?
This trial is currently completed. It is a NA study. The enrollment target is 281 participants. The study started on 2021-05-17. Estimated completion is 2025-05-17.
What interventions are being tested in trial NCT04258332?
The interventions under investigation include: High Salt Diet (DIETARY_SUPPLEMENT), Low Salt Diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04258332?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04258332's enrollment target sits among peer trials
281 380th of 2000 higher than 1,621 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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