Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01000350
First received: October 21, 2009
Last updated: January 7, 2013
Last verified: January 2013

October 21, 2009
January 7, 2013
October 2009
June 2014   (final data collection date for primary outcome measure)
Difference in VO2max between saline day and placebo day [ Time Frame: Within 2 week ] [ Designated as safety issue: No ]
VO2max will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.
Difference in VO2max between saline day and placebo day [ Time Frame: 2-10 Days between exercise tests ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01000350 on ClinicalTrials.gov Archive Site
  • Exercise capacity/Maximal Load (Watts) during peak VO2 [ Time Frame: Less than 2 weeks ] [ Designated as safety issue: No ]
    Maximal exercise load will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.
  • Cardiac output between exercise tests (inert gas rebreathing technique) [ Time Frame: 2-10 Days between exercise tests ] [ Designated as safety issue: No ]
  • Exercise capacity/Maximal Load (Watts) during peak VO2 [ Time Frame: 2-10 Days between exercise tests ] [ Designated as safety issue: No ]
  • Cardiac output between exercise tests (inert gas rebreathing technique) [ Time Frame: 2-10 Days between exercise tests ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)
Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance

The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Postural Tachycardia Syndrome
  • Drug: Saline
    IV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study
    Other Names:
    • Normal Saline
    • 0.9% saline
  • Other: Placebo
    Placebo x1 lactose tablet
    Other Name: Placebo
  • Experimental: Exercise Post Saline
    Saline infusion 1L hours before exercise test
    Intervention: Drug: Saline
  • Placebo Comparator: Placebo
    Placebo given prior to exercise test
    Intervention: Other: Placebo
Raj SR, Biaggioni I, Yamhure PC, Black BK, Paranjape SY, Byrne DW, Robertson D. Renin-aldosterone paradox and perturbed blood volume regulation underlying postural tachycardia syndrome. Circulation. 2005 Apr 5;111(13):1574-82. Epub 2005 Mar 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet diagnostic criteria of Postural Tachycardia Syndrome (POTS) 28
  • Age between 18-65 years
  • Male and female are eligible (although the majority of POTS patients are female).
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Presence of medical conditions that can explain postural tachycardia (e.g., acute dehydration, medications)
  • Pregnancy
  • Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
  • Patients who are bedridden or chair-ridden
Both
18 Years to 65 Years
No
Contact: Satish R Raj, MD MSCI adcresearch@vanderbilt.edu
United States
 
NCT01000350
090942
No
Satish R. Raj, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University
Vanderbilt University
January 2013

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