Acute Salt Handling in Orthostatic Intolerance

NCT ID: NCT00581633

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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Orthostatic Tachycardia Orthostatic Intolerance Postural Tachycardia Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

saline infusion for sodium loading

Group Type EXPERIMENTAL

normal saline (0.9%)

Intervention Type OTHER

liter normal saline over 30 minutes x 1 dose

Interventions

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normal saline (0.9%)

liter normal saline over 30 minutes x 1 dose

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Satish R. Raj

Assistant Professor of Medicine & Pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Satish R Raj, MD MSCI

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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UL1RR024975

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23RR020783

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P01HL056693

Identifier Type: NIH

Identifier Source: secondary_id

View Link

061230

Identifier Type: -

Identifier Source: org_study_id

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