Advertisement

Topics

A Study of Pyridostigmine in Postural Tachycardia Syndrome

2014-08-27 03:41:13 | 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

Published on BioPortfolio: 2014-08-27T03:41:13-0400

Clinical Trials [1227 Associated Clinical Trials listed on BioPortfolio]

Vagal Stimulation in POTS

The purpose of this study is to investigate how the electrical stimulation of a nerve in the skin of the earlobe (transcutaneous vagal nerve stimulation), alone or in combination with two ...

The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in the pathophysiology of postural tachycardia syndrome, and to provide an insight about the disease...

Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)

The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).

Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome

Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans, but predominates in women with a 5:1 ratio. Patients with POTS experience debilitating tachycard...

Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)

The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease heart rate increases on standing in patients with...

PubMed Articles [5997 Associated PubMed Articles listed on BioPortfolio]

Ivabradine in the treatment of postural tachycardia syndrome (POTS), a single center experience.

Ivabradine is a selective If  channel blocker that reduces heart rate without affecting other cardiovascular functions. In case reports and case series, it was shown to improve symptoms in patients w...

Postural Orthostatic Tachycardia Predicts Early Conversion to Multiple Sclerosis after Clinically Isolated Syndrome.

There have been suggestions that interactions exist between the autonomic nervous system (ANS) and the immune system functions in multiple sclerosis (MS). We aimed to evaluate the ANS dysfunction, mor...

Co-morbidity of vasovagal syncope and postural tachycardia syndrome with allergic diseases in children.

To explore the clinical characteristics of the co-morbidity of vasovagal syncope (VVS) and postural tachycardia syndrome (POTS) with allergic diseases in children.

Static postural sway of women with and without fibromyalgia syndrome: A cross-sectional study.

There is a frequent complaint about balance problems among fibromyalgia syndrome patients; however, there are not enough studies that have shown static postural sway of women with fibromyalgia syndrom...

Postural Tachycardia Syndrome: Diagnosis and Management in Adolescents and Young Adults.

Postural tachycardia syndrome (POTS) represents a common form of orthostatic intolerance that disproportionately affects young women from puberty through adulthood. Patients with POTS have day-to-day ...

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)

Adverse drug effects associated with CHOLINERGIC ANTAGONISTS. Clinical features include TACHYCARDIA; HYPERTHERMIA; MYDRIASIS, dry skin and dry mucous membranes, decreased bowel sounds and urinary retention in peripheral anticholinergic syndrome; and HALLUCINATIONS; PSYCHOSES; SEIZURES; and COMA in central anticholinergic syndrome.

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.

More From BioPortfolio on "A Study of Pyridostigmine in Postural Tachycardia Syndrome"

Quick Search
Advertisement
 

Relevant Topics

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...


Searches Linking to this Trial