Acute Salt Handling in Orthostatic Intolerance
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Purpose
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 | Intervention |
|---|---|
|
Postural Tachycardia Syndrome Orthostatic Tachycardia Orthostatic Intolerance |
Other: normal saline (0.9%) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Acute Renal Salt Handling in Orthostatic Intolerance |
- Urinary Na excretion [ Time Frame: 24h and then hourly post saline load ] [ Designated as safety issue: No ]
- Catecholamine levels [ Time Frame: 1 day ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
saline infusion for sodium loading
|
Other: normal saline (0.9%)
liter normal saline over 30 minutes x 1 dose
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | Satish R Raj, MD MSCI | Vanderbilt University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00581633 History of Changes |
| Other Study ID Numbers: | 061230, NIH 1 UL1 RR024975, NIH K23 RR020783, NIH P01 HL 56693 |
| Study First Received: | December 22, 2007 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
saline sodium kidney tachycardia |
Additional relevant MeSH terms:
|
Orthostatic Intolerance Mitral Valve Prolapse Neurocirculatory Asthenia Tachycardia Postural Orthostatic Tachycardia Syndrome Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Neurologic Manifestations |
Signs and Symptoms Heart Valve Prolapse Heart Valve Diseases Heart Diseases Cardiovascular Diseases Anxiety Disorders Mental Disorders Arrhythmias, Cardiac Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013