NCT00581633

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
44mo left

Started Feb 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Feb 2007Dec 2029

Study Start

First participant enrolled

February 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
21.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

October 6, 2025

Status Verified

October 1, 2025

Enrollment Period

22.8 years

First QC Date

December 22, 2007

Last Update Submit

October 3, 2025

Conditions

Postural Tachycardia SyndromeOrthostatic TachycardiaOrthostatic Intolerance

Keywords

salinesodiumkidneytachycardia

Outcome Measures

Primary Outcomes (1)

  • Urinary Na excretion

    24h and then hourly post saline load

Secondary Outcomes (1)

  • Catecholamine levels

    1 day

Study Arms (1)

1

EXPERIMENTAL

saline infusion for sodium loading

Other: normal saline (0.9%)

Interventions

normal saline (0.9%)OTHER

liter normal saline over 30 minutes x 1 dose

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with orthostatic intolerance by Vanderbilt Autonomic Dysfunction Center (or healthy control subject)

You may not qualify if:

  • Overt or acute cause for orthostatic tachycardia
  • Hypertension (BP\>145/95 or need for anti-hypertensive medications)
  • QRS duration \> 120 msec on EKG
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Links

MeSH Terms

Conditions

Postural Orthostatic Tachycardia SyndromeOrthostatic IntoleranceTachycardia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic Processes

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Satish R Raj, MD MSCI

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine & Pharmacology

Study Record Dates

First Submitted

December 22, 2007

First Posted

December 27, 2007

Study Start

February 1, 2007

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

October 6, 2025

Record last verified: 2025-10

Locations

US(1)