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

What this Trial Is About

Researchers are evaluating pyridostigmine compared to a placebo for treating postural tachycardia syndrome (POTS), a condition characterized by rapid heart rate and symptoms like weakness and lightheadedness when standing. This phase 2 study aims to see if pyridostigmine can improve heart rate and stabilize blood pressure in people with POTS. The study is double-blind and placebo-controlled, meaning neither participants nor doctors know who receives the active drug or placebo during the trial. Participants will be randomly assigned to one of two groups: one taking 180 mg of time-release pyridostigmine daily, and the other taking a placebo capsule daily, both for 3 days. The study includes two visits to the outpatient General Clinical Research Center. The first visit lasts about 3 hours, and the second visit occurs 2 days later, lasting about 2 hours. During these visits, various tests and procedures assess autonomic and cardiovascular function. During each visit, participants will undergo a medical and neurological exam, height and weight measurement, and complete questionnaires about autonomic symptoms. Tests include an autonomic reflex screen with sweat gland response, cardiovascular recordings, the Valsalva maneuver, and a head-up tilt test. Blood samples will be taken to measure hormone levels while lying down and after standing. Researchers will measure changes in orthostatic symptoms using the Composite Autonomic Symptom Scale and monitor heart rate and plasma norepinephrine changes. Safety and response will be closely observed throughout the short study period.

A Study of Pyridostigmine in Postural Tachycardia Syndrome