Clinical Trial: A Study of Pyridostigmine in Postural Tachycardia Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Double-Blind, Placebo-Controlled Study of Pyridostigmine in Postural Tachycardia Syndrome

Brief Summary: This is a 3-day study comparing pyridostigmine versus placebo in the treatment of postural tachycardia syndrome (POTS). The researchers expect pyridostigmine to improve tachycardia and stabilize blood pressure.

Detailed Summary:

The study will be done at the outpatient General Clinical Research Center (GCRC) at Charlton 7 and will involve two visits. Visit 1 will take about 3 hours, and Visit 2 will occur 2 days after Visit 1 and will take about 2 hours.

You will be put in one of two groups by chance (as in the flip of a coin). One group will be taking placebo (an inactive substance), the other group 180 mg pyridostigmine in time release formulation. Both placebo and pyridostigmine will look identical and will be taken as one capsule per day for 3 days. Neither you nor the study doctor will know at the time of treatment whether the treatment being given is active or inactive. However, in case of an emergency, this information will be available.

For each of the two visits, the following tests and procedures will be performed:

  • When you arrive at the GCRC, you will have a general medical and neurological examination and height and weight measurement.
  • Questionnaires. You will be asked to answer a series of questions on your autonomic symptoms (such as rapid heart rate, feeling of tiredness, cold and sweaty hands) at each of your two visits. The questionnaire you will be given during your first visit should take approximately 30 minutes to complete. The questionnaire you will be given during your second visit should take approximately 10 minutes to complete.

  • Autonomic Reflex Screen. An autonomic reflex screen will be done during each visit. This consists of the following:

    • Quantitative sudomotor axon reflex test (QSART): QSART is a routine clinical test that evaluates the respo
      Sponsor: Mayo Clinic

      Current Primary Outcome: Change in orthostatic symptoms using Composite Autonomic Symptom Scale (COMPASS) change [ Time Frame: 3 days ]

      Original Primary Outcome: Change in orthostatic symptoms using COMPASS change

      Current Secondary Outcome:

      • Heart rate response to head-up tilt [ Time Frame: 3 days ]
      • Plasma norepinephrine change [ Time Frame: 3 days ]


      Original Secondary Outcome:

      • Heart rate response to head-up tilt
      • Plasma norepinephrine change


      Information By: Mayo Clinic

      Dates:
      Date Received: December 6, 2006
      Date Started: October 2006
      Date Completion: February 2019
      Last Updated: March 21, 2017
      Last Verified: March 2017