Back to resultsIntravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)
Primary Purpose
Postural Tachycardia Syndrome
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postural Tachycardia Syndrome focused on measuring orthostatic intolerance, exercise capacity, tachycardia, POTS
Eligibility Criteria
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
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exercise Post Saline
Placebo
Arm Description
Saline infusion 1L hours before exercise test
Placebo given prior to exercise test
Outcomes
Primary Outcome Measures
Difference in VO2max between saline day and placebo day
VO2max will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.
Secondary Outcome Measures
Exercise capacity/Maximal Load (Watts) during peak VO2
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)
Full Information
NCT ID
NCT01000350
First Posted
October 21, 2009
Last Updated
September 20, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01000350
Brief Title
Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)
Official Title
Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Tachycardia Syndrome
Keywords
orthostatic intolerance, exercise capacity, tachycardia, POTS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Post Saline
Arm Type
Experimental
Arm Description
Saline infusion 1L hours before exercise test
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given prior to exercise test
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Normal Saline, 0.9% saline
Intervention Description
IV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo x1 lactose tablet
Primary Outcome Measure Information:
Title
Difference in VO2max between saline day and placebo day
Description
VO2max will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.
Time Frame
Within 2 week
Secondary Outcome Measure Information:
Title
Exercise capacity/Maximal Load (Watts) during peak VO2
Description
Maximal exercise load will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.
Time Frame
Less than 2 weeks
Title
Cardiac output between exercise tests (inert gas rebreathing technique)
Time Frame
2-10 Days between exercise tests
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish R Raj, MD MSCI
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15781744
Citation
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. doi: 10.1161/01.CIR.0000160356.97313.5D. Epub 2005 Mar 21.
Results Reference
background
Learn more about this trial
Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)
We'll reach out to this number within 24 hrs