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

Not Applicable

Active, not recruiting

• Conditions: Postural Tachycardia Syndrome
• Interventions: Drug: Saline; Other: Placebo

• Registration Number: NCT01000350
• Lead Sponsor: Vanderbilt University Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exercise Post Saline	Saline	Saline infusion 1L hours before exercise test
Placebo	Placebo	Placebo given prior to exercise test

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States