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Autoimmune Investigation for POTS
N/A
Waitlist Available
Led By Luis Okamoto, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-50 years old
Be between 18 and 65 years old
Must not have
Hypertension (>150 mmHg systolic and >100 mmHg diastolic) based on history or findings at screening.
Cardiovascular disease, such as myocardial infarction within 6 months, angina pectoris, significant arrhythmia (sinus tachycardia is not excluded), deep vein thrombosis, pulmonary embolism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 minutes
Awards & highlights
Summary
This trial is studying whether certain immune proteins are causing or worsening symptoms in people with POTS, a condition that makes it hard for them to stand without feeling dizzy or faint. The researchers will study people with POTS to see if these proteins are more common in those with the condition and if these levels vary.
Who is the study for?
This trial is for people aged 18-50 with Postural Tachycardia Syndrome (POTS), which causes a rapid heartbeat upon standing. Participants must have had symptoms for over 6 months and be able to follow the study's procedures. Pregnant individuals, those with recent heart issues or significant arrhythmias, liver or kidney problems, low hematocrit levels, uncontrolled hypertension, serious neurological diseases, or immune/hematological disorders cannot join.
What is being tested?
The study tests if autoantibodies against autonomic nervous system receptors are present in POTS patients and affect their symptoms. It includes various diagnostic tests like microneurography, blood pressure monitoring over 24 hours, posture studies with blood samples involving minimal radiation exposure, and autonomic function assessments.
What are the potential side effects?
Potential side effects may include discomfort from prolonged standing during testing; reactions at the site of blood draws; temporary changes in heart rate or blood pressure due to medication like phenylephrine or isoproterenol used during some tests; and minimal radiation exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood pressure is higher than 150/100 mmHg.
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I have not had a heart attack, severe chest pain, serious irregular heartbeat, deep vein thrombosis, or lung blood clots in the last 6 months.
Select...
My liver tests are higher than normal.
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My kidney function is impaired with high creatinine levels.
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I have a history of serious neurological disease.
Select...
My blood pressure drops significantly when I stand up.
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I have a significant immune or blood disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Autoantibody levels
Orthostatic change in heart rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Autonomic and Antibody AssessmentsExperimental Treatment10 Interventions
On up to 3 study days, POTS patients and control subjects will have several tests to assess autonomic function and to detect the presence of autoantibodies to adrenergic receptors. The following tests will de done but in some participants it may not be necessary to do all of them. The investigator will discuss with each participant which particular tests will be done in each particular case:
* Posture study with blood samples for autoantibody testing
* 24-hour heart rhythm and blood pressure monitoring
* autonomic function tests
* Quantitative Axonal Sudomotor Reflex Testing
* Total blood volume assessment
* Pharmacologic testing with phenylephrine
* Pharmacologic testing with isoproterenol
* Cardiac output with rebreathing
* Assessment of splanchnic capacitance
* Microneurography
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phenylephrine
FDA approved
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Postural Orthostatic Tachycardia Syndrome (POTS) treatments often target the autonomic nervous system to manage symptoms. Common treatments include beta-blockers, which reduce heart rate and improve blood flow, and fludrocortisone, which increases blood volume.
Additionally, intravenous immunoglobulin (IVIG) and immunosuppressants like rituximab are used to reduce the activity of autoantibodies that may target autonomic receptors. These treatments are crucial for POTS patients as they address the underlying dysregulation of the autonomic nervous system, potentially linked to autoantibodies, thereby alleviating symptoms such as tachycardia and improving quality of life.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
892 Previous Clinical Trials
936,463 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
872 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
University of OklahomaOTHER
466 Previous Clinical Trials
91,165 Total Patients Enrolled
2 Trials studying Postural Orthostatic Tachycardia Syndrome
85 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Luis Okamoto, MDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
31 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 50 years old.My heart rate increases significantly when I stand up, without a drop in blood pressure, and this has been happening for more than 6 months.My blood pressure is higher than 150/100 mmHg.I have not had a heart attack, severe chest pain, serious irregular heartbeat, deep vein thrombosis, or lung blood clots in the last 6 months.My liver tests are higher than normal.My kidney function is impaired with high creatinine levels.I don't have any health conditions that could interfere with the study.I have a history of serious neurological disease.I don't have any conditions that could interfere with the study drug's effects.You have a serious stomach or intestine problem that could make it hard for you to eat properly or absorb medicine.Your hematocrit level is less than 28%.My blood pressure drops significantly when I stand up.I have a significant immune or blood disorder.I am using birth control and agree to pregnancy tests if I am premenopausal.
Research Study Groups:
This trial has the following groups:- Group 1: Autonomic and Antibody Assessments
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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