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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01000350

Collaborator

(none)

Enrollment

Location

Arms

176

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Postural Tachycardia Syndrome	Drug: Saline Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance

Study Start Date :

Oct 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Post Saline Saline infusion 1L hours before exercise test	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
Placebo Comparator: Placebo Placebo given prior to exercise test	Other: Placebo Placebo x1 lactose tablet

Arm

Intervention/Treatment

Experimental: Exercise Post Saline

Saline infusion 1L hours before exercise test

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

Placebo Comparator: Placebo

Placebo given prior to exercise test

Other: Placebo

Placebo x1 lactose tablet

Outcome Measures

Primary Outcome Measures

Difference in VO2max between saline day and placebo day [Within 2 week]
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 [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) [2-10 Days between exercise tests]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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