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

This study is currently recruiting participants.
Verified January 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01000350
First received: October 21, 2009
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Difference in VO2max between saline day and placebo day [ Time Frame: Within 2 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000350

Contacts
Contact: Satish R Raj, MD MSCI adcresearch@vanderbilt.edu

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

Additional Information:
Vanderbilt Autonomic Dysfunction Center Website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01000350     History of Changes
Other Study ID Numbers: 090942
Study First Received: October 21, 2009
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
orthostatic intolerance
exercise capacity
tachycardia
POTS

Additional relevant MeSH terms:
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Orthostatic Intolerance
Mitral Valve Prolapse
Neurocirculatory Asthenia
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
 Signs and Symptoms
Heart Valve Prolapse
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Anxiety Disorders
Mental Disorders
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013