The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).
Full Title of Study: “Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 2021
- Drug: Saline
- IV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study
- Other: Placebo
- Placebo x1 lactose tablet
Arms, Groups and Cohorts
- Experimental: Exercise Post Saline
- Saline infusion 1L hours before exercise test
- Placebo Comparator: Placebo
- Placebo given prior to exercise test
Clinical Trial Outcome Measures
- 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.
- 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
Participating in This Clinical Trial
- 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
- Presence of medical conditions that can explain postural tachycardia (e.g., acute dehydration, medications)
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
- Patients who are bedridden or chair-ridden
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Vanderbilt University
- Provider of Information About this Clinical Study
- Principal Investigator: Satish R. Raj, Adjunct Associate Professor of Medicine – Vanderbilt University Medical Center
- Overall Official(s)
- Satish R Raj, MD MSCI, Principal Investigator, Vanderbilt University
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.
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