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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000350
First Posted: October 23, 2009
Last Update Posted: July 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University Medical Center
  Purpose
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 Intervention
Postural Tachycardia Syndrome Drug: Saline Other: Placebo

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance

Resource links provided by NLM:


Further study details as provided by Satish R. Raj, Vanderbilt University Medical Center:

Primary 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: October 2009
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000350


Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-2195
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University
  More Information

Additional Information:
Publications:
Responsible Party: Satish R. Raj, Adjunct Associate Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01000350     History of Changes
Other Study ID Numbers: 090942
First Submitted: October 21, 2009
First Posted: October 23, 2009
Last Update Posted: July 17, 2017
Last Verified: July 2017

Keywords provided by Satish R. Raj, Vanderbilt University Medical Center:
orthostatic intolerance
exercise capacity
tachycardia
POTS

Additional relevant MeSH terms:
Syndrome
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Orthostatic Intolerance
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms