What side effects are associated with this type of intervention?

Common treatments for Postural Orthostatic Tachycardia Syndrome (POTS) that lower sympathetic activity, such as Moxonidine, can have side effects including dry mouth, dizziness, fatigue, and insomnia. These medications work by reducing the activity of the sympathetic nervous system, which can help manage heart rate and blood pressure but may also lead to these adverse effects. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Postural Orthostatic Tachycardia Syndrome (POTS) in the provided context. However, Moxonidine, which is being studied for its potential to lower sympathetic activity and improve symptoms in POTS patients, represents a class of medications that target the sympathetic nervous system. Other drugs that lower sympathetic activity, such as alpha-2 adrenergic agonists like clonidine and dexmedetomidine, have shown effects on related conditions but are not specifically noted for POTS treatment in the context provided.

What other types of research exist?

Promising novel alternatives to Moxonidine for POTS patients include ivabradine, which reduces heart rate by inhibiting the If current in the sinoatrial node, and droxidopa, which is a norepinephrine precursor that can improve symptoms of orthostatic intolerance. Additionally, non-pharmacological approaches such as physical counter-maneuvers, increased fluid and salt intake, and compression garments are also recommended.

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Blood Pressure Medication

Moxonidine for Postural Orthostatic Tachycardia Syndrome (POTS)

Q: What is the mechanism of action of this treatment?

The most common treatments for Postural Orthostatic Tachycardia Syndrome (POTS) often focus on reducing sympathetic nervous system activity, which is typically overactive in POTS patients. Moxonidine, for example, lowers sympathetic activity by acting on central imidazoline receptors, which helps to reduce heart rate and improve symptoms during standing. This is crucial for POTS patients because excessive sympathetic activity can lead to high heart rates and significant discomfort upon standing. By targeting the sympathetic nervous system, these treatments aim to stabilize heart rate and improve overall quality of life for POTS patients.

Phase < 1

Waitlist Available

Led By André Diedrich, 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

Female/male subjects, age 18-55 years

POTS with primary central sympathetic activation (psPOTS) as defined as having resting muscle sympathetic nerve activity (MSNA) greater than or equal to 25 bursts/min

Must not have

Treatment with oral corticosteroids, current infections (e.g., urinary tract infection), or use of non-steroidal anti-inflammatory drugs

Arteriosclerotic disease of carotid artery. History of neck surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 30 min supine to after 15 min upright (delta voss), 2-3 hours after placebo or moxonidine intake [delta (delta voss)].

Summary

This trial tests Moxonidine, a medication that calms overactive nerves controlling blood pressure and heart rate, on patients with POTS who have high nerve activity. The goal is to see if it can lower heart rate and improve symptoms when standing. Moxonidine is designed to reduce blood pressure with fewer side effects compared to older medications.

Who is the study for?

This trial is for men and women aged 18-55 with Postural Orthostatic Tachycardia Syndrome (POTS) characterized by a rapid heartbeat upon standing. Participants must have high resting sympathetic nerve activity, not be pregnant or severely overweight, and cannot be taking certain medications that affect autonomic function.

What is being tested?

The study tests the effect of Moxonidine, a blood pressure medication that reduces sympathetic nerve activity, on POTS symptoms compared to a placebo. The goal is to see if it can lower heart rate and improve symptoms when standing in patients with high sympathetic activity.

What are the potential side effects?

Moxonidine may cause side effects such as dry mouth, drowsiness, headache, fatigue, skin reactions or gastrointestinal issues. As it lowers blood pressure and heart rate, some individuals might experience dizziness or fainting.

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 55 years old.

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I have been diagnosed with a specific type of POTS based on nerve activity tests.

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I am between 18 and 55 years old.

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My heart rate increases significantly when I stand up, without a drop in blood pressure, and I've felt this way for over 6 months.

Exclusion Criteria

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

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I am not currently taking oral corticosteroids, have no infections, and am not using NSAIDs.

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I have hardening of the neck arteries or have had neck surgery.

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I cannot stop taking my medication that affects my blood pressure or heart function.

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My physical fitness level is lower than expected for my age and sex.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 30 min supine to after 15 min upright (delta hr), 2-3 hours after placebo or moxonidine intake [delta (delta hr)].

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 30 min supine to after 15 min upright (delta hr), 2-3 hours after placebo or moxonidine intake [delta (delta hr)].

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 30 min supine to after 15 min upright (delta hr), 2-3 hours after placebo or moxonidine intake [delta (delta hr)]. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Orthostatic Symptom Burden [delta (delta VOSS)]

Secondary study objectives

Change in Orthostatic Change in Heart Rate [delta (delta HR)]

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MoxonidineExperimental Treatment1 Intervention

Patients will receive a single oral dose of moxonidine 0.4 mg.

Group II: PlaceboPlacebo Group1 Intervention

Patients will receive a single oral dose of placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Moxonidine

2011

Completed Phase 4

~480

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

The most common treatments for Postural Orthostatic Tachycardia Syndrome (POTS) often focus on reducing sympathetic nervous system activity, which is typically overactive in POTS patients. Moxonidine, for example, lowers sympathetic activity by acting on central imidazoline receptors, which helps to reduce heart rate and improve symptoms during standing. This is crucial for POTS patients because excessive sympathetic activity can lead to high heart rates and significant discomfort upon standing. By targeting the sympathetic nervous system, these treatments aim to stabilize heart rate and improve overall quality of life for POTS patients.