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Acute Salt Handling in Orthostatic Intolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00581633
Recruitment Status : Active, not recruiting
First Posted : December 27, 2007
Last Update Posted : September 8, 2021
National Center for Research Resources (NCRR)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Postural Tachycardia Syndrome Orthostatic Tachycardia Orthostatic Intolerance Other: normal saline (0.9%) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Acute Renal Salt Handling in Orthostatic Intolerance
Study Start Date : February 2007
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
saline infusion for sodium loading
Other: normal saline (0.9%)
liter normal saline over 30 minutes x 1 dose

Primary Outcome Measures :
  1. Urinary Na excretion [ Time Frame: 24h and then hourly post saline load ]

Secondary Outcome Measures :
  1. Catecholamine levels [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00581633

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United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Center for Research Resources (NCRR)
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University
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Responsible Party: Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University Identifier: NCT00581633    
Other Study ID Numbers: 061230
UL1RR024975 ( U.S. NIH Grant/Contract )
K23RR020783 ( U.S. NIH Grant/Contract )
P01HL056693 ( U.S. NIH Grant/Contract )
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Keywords provided by Satish R. Raj, Vanderbilt University:
Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Orthostatic Intolerance
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations