What side effects are associated with this type of intervention?

Common treatments for Postural Orthostatic Tachycardia Syndrome (POTS) include beta-blockers, fludrocortisone, and midodrine. Beta-blockers can cause fatigue, cold extremities, and bradycardia. Fludrocortisone may lead to fluid retention, hypertension, and hypokalemia. Midodrine can cause piloerection, pruritus, and supine hypertension. Treatments involving immune modulation, such as intravenous immunoglobulin (IVIG) or immunosuppressants, may cause side effects like infusion reactions, increased risk of infections, and potential kidney dysfunction.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs for the treatment of Postural Orthostatic Tachycardia Syndrome (POTS). Treatment typically involves a combination of lifestyle modifications, such as increased fluid and salt intake, and off-label use of medications like beta-blockers, fludrocortisone, and midodrine to manage symptoms. The study on autoantibodies targeting autonomic nervous system receptors is exploring a novel aspect of POTS, but no treatments specifically targeting these autoantibodies have been approved yet.

What other types of research exist?

Promising novel alternatives for POTS patients in 2024 may include: 1) Non-pharmacological interventions like tailored physical therapy and exercise programs to improve autonomic function. 2) Advanced pharmacological treatments targeting specific symptoms or underlying mechanisms, such as ivabradine for heart rate control. 3) Use of wearable technology for continuous monitoring of vital signs and autonomic function, providing real-time data to tailor treatments. 4) Genetic and molecular profiling to identify personalized treatment strategies.

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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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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 below

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I am between 18 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 minutes for reporting.

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

Awards & Highlights

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.

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

0 / 8Eligibility criteria met

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.