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

Postural Tachycardia Syndrome Clinical Trial

Official title:

Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01000350
• Other study ID #: 090942
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2009
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthostatic Intolerance
• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Syndrome
• Tachycardia

Intervention

Drug:
• Saline
IV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study

Other:
• Placebo
Placebo x1 lactose tablet

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 2 week
Secondary	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.	Less than 2 weeks
Secondary	Cardiac output between exercise tests (inert gas rebreathing technique)		2-10 Days between exercise tests