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NCT00581633 Clinical Trial

Acute Salt Handling in Orthostatic Intolerance

Postural Tachycardia Syndrome Clinical Trial

Official title:
Acute Renal Salt Handling in Orthostatic Intolerance

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00581633
Other study ID # 061230
Secondary ID UL1RR024975K23RR
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 2007
Est. completion date December 2025

Study information
Verified date September 2023
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• normal saline (0.9%)
liter normal saline over 30 minutes x 1 dose

Locations
Country Name City State
United States Vanderbilt University Nashville Tennessee

Sponsors (3)
Lead Sponsor Collaborator
Vanderbilt University National Center for Research Resources (NCRR), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urinary Na excretion 24h and then hourly post saline load
Secondary Catecholamine levels 1 day
See also
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Recruiting NCT05618054 - Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities? N/A
Completed NCT01366963 - Cognitive Dysfunction in Postural Tachycardia Syndrome N/A
Recruiting NCT05107635 - Inappropriate Sinus Tachycardia Registry
Terminated NCT02154009 - Clinical Autonomic Disorders: A Training Protocol
Completed NCT03602482 - Standing Cognition and Co-morbidities of POTS Evaluation N/A
Completed NCT02167412 - EEG Characteristics in Youth POTS and/or Syncope

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