A Study of Pyridostigmine in Postural Tachycardia Syndrome

17:15 EDT 24th October 2014 | BioPortfolio

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.

Description

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 response of the sweat gland to a drug, acetylcholine. One capsule is placed on your forearm and three on your leg and foot. The testing is done by passing a small electrical current, for 5 minutes, to activate the nerves that supply the sweat glands. You will feel a slight burning sensation.

- Cardiovascular recordings: Blood pressure, heart rate, and other cardiovascular measurements will be studied by placing electrodes on the chest and a finger or wrist cuff for continuous blood pressure recordings.

- Valsalva maneuver: This involves blowing very hard into a bugle (like blowing up a balloon) for 15 seconds.

- Head-up tilt: Following a period of rest (at least 5 minutes), you will be tilted up to an angle of not more than 80 degrees and recordings will be made for up to 30 minutes. On Visit 1, one hour after you have taken the study medication, this test will be repeated. This test will be done only once on Visit 2.

- Hormone level measurements: This will be done during each visit. An IV will be inserted into a vein in your arm from which approximately one teaspoon of blood will be drawn while you are lying down and one teaspoon after standing up. This will be repeated only on Visit 1, one hour after the study drug is given. A total of four teaspoons of blood will be drawn on Visit 1 and 2 teaspoons will be drawn on Visit 2.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Postural Tachycardia Syndrome

Intervention

pyridostigmine, Placebo

Location

Mayo Clinic
Rochester
Minnesota
United States
55905

Status

Recruiting

Source

Mayo Clinic

Results (where available)

View Results

Links

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The study compares three treatment modalities in a human model of Postural orthostatic tachycardia syndrome (POTS): beta-blockers, I(f)-blockers, and placebo.

PubMed Articles [6709 Associated PubMed Articles listed on BioPortfolio]

Hemodynamic Profiles and Tolerability of Modafinil in the Treatment of Postural Tachycardia Syndrome: A Randomized, Placebo-Controlled Trial.

Postural tachycardia syndrome (POTS) is characterized clinically not only by an exaggerated increase in heart rate (HR), but an associated cognitive impairment that disables many patients. Modafinil m...

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Quantitative and qualitative abnormalities in visceral function have been demonstrated in postural orthostatic tachycardia syndrome. Joint hypermobility is frequently associated with both postural ort...

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Postural tachycardia syndrome (POTS) shows a marked tachycardia while standing. We noticed two forms of circulatory response to orthostatic stress in POTS. We investigated cardiovascular and autonomic...

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We described a heterogenous group of children disabled by postural tachycardia syndrome (POTS) and evident orthostatic hypertension (OHT).

Usefulness of Plasma Copeptin as a Biomarker to Predict the Therapeutic Effectiveness of Metoprolol for Postural Tachycardia Syndrome in Children.

Metoprolol is clinically used to treat postural tachycardia syndrome (POTS) in children, but its effectiveness is unsatisfactory. Biomarkers to predict therapeutic efficacy are needed. We aimed to exp...

Medical and Biotech [MESH] Definitions

A syndrome of ORTHOSTATIC INTOLERANCE combined with excessive upright TACHYCARDIA, and usually without associated ORTHOSTATIC HYPOTENSION. All variants have in common an excessively reduced venous return to the heart (central HYPOVOLEMIA) while upright.

Symptoms of cerebral hypoperfusion or autonomic overaction which develop while the subject is standing, but are relieved on recumbency. Types of this include NEUROCARDIOGENIC SYNCOPE; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME; and neurogenic ORTHOSTATIC HYPOTENSION. (From Noseworthy, JH., Neurological Therapeutics Principles and Practice, 2007, p2575-2576)

A malignant form of polymorphic ventricular tachycardia that is characterized by HEART RATE between 200 and 250 beats per minute, and QRS complexes with changing amplitude and twisting of the points. The term also describes the syndrome of tachycardia with prolonged ventricular repolarization, long QT intervals exceeding 500 milliseconds or BRADYCARDIA. Torsades de pointes may be self-limited or may progress to VENTRICULAR FIBRILLATION.

A generic expression for any tachycardia that originates above the BUNDLE OF HIS.

A POSTURE in which an ideal body mass distribution is achieved. Postural balance provides the body carriage stability and conditions for normal functions in stationary position or in movement, such as sitting, standing, or walking.

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