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

NCT01000350 | Active Not Recruiting

• 1 other identifier: 090942
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Postural Tachycardia Syndrome

Keywords

orthostatic intolerance; exercise capacity; tachycardia; POTS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Exercise capacity/Maximal Load (Watts) during peak VO2

  Less than 2 weeks

• Cardiac output between exercise tests (inert gas rebreathing technique)

  2-10 Days between exercise tests

Study Arms (2)

Exercise Post Saline

EXPERIMENTAL

Saline infusion 1L hours before exercise test

Drug: Saline

Placebo

PLACEBO COMPARATOR

Placebo given prior to exercise test

Other: Placebo

Interventions

Saline DRUG

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

Also known as: Normal Saline, 0.9% saline

Exercise Post Saline

Placebo OTHER

Placebo x1 lactose tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232-2195, United States

Location

Related 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.

  PMID: 15781744 BACKGROUND

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance; Tachycardia

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Satish R Raj, MD MSCI

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor of Medicine

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 23, 2009
• Study Start: October 1, 2009
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

US (1)