Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-02 @ 4:03 PM
Study NCT ID:
NCT00581633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2007-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Salt Handling in Orthostatic Intolerance
Sponsor:
Vanderbilt University
Organization:
Study Overview
Official Title:
Acute Renal Salt Handling in Orthostatic Intolerance
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will test the hypothesis that patients with chronic orthostatic intolerance or postural orthostatic tachycardia syndrome (OI or POTS) will be unable to conserve urinary sodium as compared to healthy control subjects.
Detailed Description:
Patients with chronic OI appear to be hypovolemic with abnormalities in hormones that regulate salt \& water handling. Increases in dietary salt have salutary effects on orthostatic tolerance in a physiological laboratory. The infusion of intravenous saline acutely decreased heart rate in this patient population. Preliminary data from Vanderbilt suggests abnormal salt handling in patients with chronic OI in a few patients. These data need to be confirmed and a better understanding of sodium handling in response to acute salt loads is required in these patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UL1RR024975 | NIH | None | https://reporter.nih.gov/quic… | View |
| K23RR020783 | NIH | None | https://reporter.nih.gov/quic… | View |
| P01HL056693 | NIH | None | https://reporter.nih.gov/quic… | View |