search
Back to results

Acute Salt Handling in Orthostatic Intolerance

Primary Purpose

Postural Tachycardia Syndrome, Orthostatic Tachycardia, Orthostatic Intolerance

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
normal saline (0.9%)
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postural Tachycardia Syndrome focused on measuring saline, sodium, kidney, tachycardia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

saline infusion for sodium loading

Outcomes

Primary Outcome Measures

Urinary Na excretion

Secondary Outcome Measures

Catecholamine levels

Full Information

First Posted
December 22, 2007
Last Updated
September 20, 2023
Sponsor
Vanderbilt University
Collaborators
National Center for Research Resources (NCRR), National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00581633
Brief Title
Acute Salt Handling in Orthostatic Intolerance
Official Title
Acute Renal Salt Handling in Orthostatic Intolerance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Center for Research Resources (NCRR), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Tachycardia Syndrome, Orthostatic Tachycardia, Orthostatic Intolerance
Keywords
saline, sodium, kidney, tachycardia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
saline infusion for sodium loading
Intervention Type
Other
Intervention Name(s)
normal saline (0.9%)
Intervention Description
liter normal saline over 30 minutes x 1 dose
Primary Outcome Measure Information:
Title
Urinary Na excretion
Time Frame
24h and then hourly post saline load
Secondary Outcome Measure Information:
Title
Catecholamine levels
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish R Raj, MD MSCI
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.vumc.org/autonomic-dysfunction-center/vanderbilt-autonomic-dysfunction
Description
Vanderbilt Autonomic Dysfunction Center

Learn more about this trial

Acute Salt Handling in Orthostatic Intolerance

We'll reach out to this number within 24 hrs