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Acute Salt Handling in Orthostatic Intolerance

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ClinicalTrials.gov Identifier: NCT00581633
Recruitment Status : Active, not recruiting
First Posted : December 27, 2007
Last Update Posted : September 8, 2021
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE December 22, 2007
First Posted Date  ICMJE December 27, 2007
Last Update Posted Date September 8, 2021
Study Start Date  ICMJE February 2007
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2007)
Urinary Na excretion [ Time Frame: 24h and then hourly post saline load ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2007)
Catecholamine levels [ Time Frame: 1 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Salt Handling in Orthostatic Intolerance
Official Title  ICMJE Acute Renal Salt Handling in Orthostatic Intolerance
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Postural Tachycardia Syndrome
  • Orthostatic Tachycardia
  • Orthostatic Intolerance
Intervention  ICMJE Other: normal saline (0.9%)
liter normal saline over 30 minutes x 1 dose
Study Arms  ICMJE Experimental: 1
saline infusion for sodium loading
Intervention: Other: normal saline (0.9%)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 22, 2007)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00581633
Other Study ID Numbers  ICMJE 061230
UL1RR024975 ( U.S. NIH Grant/Contract )
K23RR020783 ( U.S. NIH Grant/Contract )
P01HL056693 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Satish R. Raj, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE
  • National Center for Research Resources (NCRR)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP