Overview

This trial is active, not recruiting.

Condition postural tachycardia syndrome
Treatments saline, placebo
Sponsor Vanderbilt University
Start date October 2009
End date June 2017
Trial size 40 participants
Trial identifier NCT01000350, 090942

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Saline infusion 1L hours before exercise test
saline Normal Saline
IV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study
(Placebo Comparator)
Placebo given prior to exercise test
placebo
Placebo x1 lactose tablet

Primary Outcomes

Measure
Difference in VO2max between saline day and placebo day
time frame: Within 2 week

Secondary Outcomes

Measure
Exercise capacity/Maximal Load (Watts) during peak VO2
time frame: Less than 2 weeks
Cardiac output between exercise tests (inert gas rebreathing technique)
time frame: 2-10 Days between exercise tests

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance
Principal investigator Satish R Raj, MD MSCI
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.