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Clinical Trials/NCT00581633
NCT00581633Active, not recruitingNot Applicable

Acute Renal Salt Handling in Orthostatic Intolerance

Vanderbilt University2 sites in 1 country30 target enrollmentStarted: February 1, 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
30
Locations
2
Primary Endpoint
Urinary Na excretion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Urinary Na excretion

Time Frame: 24h and then hourly post saline load

Secondary Outcomes

  • Catecholamine levels(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Satish R. Raj

Assistant Professor of Medicine & Pharmacology

Vanderbilt University

Study Sites (2)

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