Testing pyridostigmine for treating postural tachycardia syndrome
Double-Blind, Placebo-Controlled Study of Pyridostigmine in Postural Tachycardia Syndrome
PHASE2 · Mayo Clinic · NCT00409435
This study tests if the medication pyridostigmine can help people with postural tachycardia syndrome feel better by improving their heart rate and blood pressure compared to a placebo.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 15 Years to 55 Years |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT00409435 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of pyridostigmine compared to a placebo in patients with postural tachycardia syndrome (POTS) over a 3-day period. Participants will be randomly assigned to receive either the medication or a placebo, with both groups undergoing medical examinations and questionnaires to assess their symptoms. The study aims to determine if pyridostigmine can improve heart rate and stabilize blood pressure in affected individuals. Two visits to the outpatient General Clinical Research Center will be required for assessments.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with postural tachycardia syndrome who meet specific diagnostic criteria.
Not a fit: Patients with other significant health issues or those who have previously used pyridostigmine for POTS may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms of POTS and improve quality of life for patients.
How similar studies have performed: While there have been studies on POTS treatments, the specific use of pyridostigmine in this context is less common, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Diagnosis of postural tachycardia syndrome using the following criteria: * Orthostatic heart rate increment greater than or equal to 30 beats per minute (bpm) within 5 minutes of head-up tilt. * Symptoms of orthostatic intolerance. These include weakness, lightheadedness, blurred vision, nausea, palpitations, and difficulty with concentration and thinking. Both criteria must be fulfilled. Exclusion Criteria: * Pregnant or lactating women * Presence of failure of other organ systems or systemic illness that could affect autonomic function or the patient's ability to cooperate with the study * Hypothyroidism or hyperthyroidism * Clinically significant coronary artery disease * Medications that could interfere with autonomic testing * Previous treatment with pyridostigmine for POTS. Patients must not have taken pyridostigmine in the past month
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Wolfgang Singer, M.D. — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postural Tachycardia Syndrome, Postural tachycardia syndrome