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NCT04244604 · ClinicalTrials.gov registry record · NA
Vascular Effects of Acute Sodium (VEAS) Study
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 71
- Enrollment target
NCT04244604: Completed NA study, sponsored by Indiana University.
NCT04244604 is a NA study that has completed, run by Indiana University. The registered enrollment target is 71 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04244604, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 71 participants
- Enrollment target
Study Summary
This IRB will cover a current clinical trial (NCT04244604) that was started at Auburn University (AU IRB#19-390), the Principal Investigator's prior institution, and is supported by his NIH Career Development Award (NHLBI K01HL147998). About nine out of ten Americans overconsume dietary salt. Compared to other racial groups, Black individuals are more prone to salt-sensitive hypertension and negative cardiovascular conditions associated with high salt intake. However, there is a critical need to determine the reasons behind and mechanisms that contribute to these racial disparities. Both acute (single meal) and chronic high-dietary sodium cause small but important increases in blood sodium concentration that are associated with altered blood pressure regulation and blood vessel dysfunction. However, racial differences in these measures have not been examined. This is important because Black individuals generally exhibit lower circulating concentrations of hormones (e.g., renin, aldosterone, angiotensin 2) that buffer changes in body sodium to regulate blood pressure, and this could make them more vulnerable to the negative effects of a high-sodium meal. Therefore, the purpose of this study is to determine whether there are racial differences in blood pressure regulation and blood flow after a high-sodium meal. The investigators will assess blood pressure regulation, blood vessel stiffness, and the blood vessel's ability to dilate before and after a high-salt meal and a low-salt control meal (both meals are low-salt tomato soup with varied added salt). The investigators will also collect blood and urine to measure sodium and determine biochemical changes that may be contributing to racial differences in cardiovascular function.
Primary Outcome
The investigators will measure systolic and diastolic pressure using photoplethysmography at the finger. Systolic and diastolic blood pressure will be assessed at rest and during handgrip exercise. Blood pressure reactivity will be expressed as a change in pressure (mmHg) from baseline to a predetermined time during the stressor (e.g., minute one average and minute two average).
Interventions
- OTHER Low Sodium Meal (140 mg sodium chloride)
- OTHER High Sodium Meal (2500 mg sodium chloride)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2025-12-15 |
| Phase | NA |
What the finished NCT04244604 record still lists
NCT04244604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Low Sodium Meal (140 mg sodium chloride) is the first listed.
NCT04244604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04244604 about?
NCT04244604 is a clinical study titled "Vascular Effects of Acute Sodium (VEAS) Study". This IRB will cover a current clinical trial (NCT04244604) that was started at Auburn University (AU IRB#19-390), the Principal Investigator's prior institution, and is supported by his NIH Career Development Award (NHLBI K01HL147998). About nine out of ten Americans overconsume dietary salt. Compa...
What is the current status of trial NCT04244604?
This trial is currently completed. It is a NA study. The enrollment target is 71 participants. The study started on 2021-05-03. Estimated completion is 2025-12-15.
What interventions are being tested in trial NCT04244604?
The interventions under investigation include: Low Sodium Meal (140 mg sodium chloride) (OTHER), High Sodium Meal (2500 mg sodium chloride) (OTHER).
Who is sponsoring clinical trial NCT04244604?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04244604's enrollment target sits among peer trials
71 1102nd of 2000 higher than 898 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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