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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000350
First Posted: October 23, 2009
Last Update Posted: July 17, 2017
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.
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University Medical Center
October 21, 2009
October 23, 2009
July 17, 2017
October 2009
June 2020   (Final data collection date for primary outcome measure)
Difference in VO2max between saline day and placebo day [ Time Frame: Within 2 week ]
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 ]
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 ]
    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 ]
  • Exercise capacity/Maximal Load (Watts) during peak VO2 [ Time Frame: 2-10 Days between exercise tests ]
  • Cardiac output between exercise tests (inert gas rebreathing technique) [ Time Frame: 2-10 Days between exercise tests ]
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
Intervention Model: Crossover Assignment
Masking: None (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
  • 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.
 
Active, not recruiting
40
June 2020
June 2020   (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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01000350
090942
No
Not Provided
Not Provided
Satish R. Raj, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University
Vanderbilt University Medical Center
July 2017

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