Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409435
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2006-12-06
Brief Title:
A Study of Pyridostigmine in Postural Tachycardia Syndrome
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Double-Blind Placebo-Controlled Study of Pyridostigmine in Postural Tachycardia Syndrome
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01NS044233 | NIH | None | httpsreporternihgovquickSearchP01NS044233 |