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Blood Pressure Medication

Moxonidine for Postural Orthostatic Tachycardia Syndrome

Phase < 1

Recruiting

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

Meets criteria for postural tachycardia syndrome (POTS)

POTS with primary central sympathetic activation (psPOTS) as defined as having resting MSNA ≥ 25 bursts/min

Must not have

Unable to withdraw from medications known to affect autonomic function, blood pressure or blood volume

History of neck surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 30 min supine to after 15 min of 60 degrees upright tilt (delta hr), 2-3 hours after a dose of the treatment assigned for the previous period.

Summary

This trial will help determine if a blood pressure medication can improve symptoms in people with POTS, a condition characterized by a high heart rate and disabling symptoms during standing.

Who is the study for?

This trial is for young women with POTS, a condition causing rapid heartbeat when standing. Participants must have had symptoms for at least 6 months, experience a heart rate increase of ≥30 bpm within 10 minutes of standing without significant blood pressure drops, and be in the early phase of their menstrual cycle. They should not be overweight or suffering from conditions like heart disease, high blood pressure, diabetes, or taking certain medications.

What is being tested?

The study tests Moxonidine's effect on POTS symptoms compared to a placebo. Moxonidine is a blood pressure medication that reduces sympathetic nerve activity which might help lower heart rate and improve standing tolerance in patients with high resting sympathetic activity.

What are the potential side effects?

Moxonidine may cause side effects such as dry mouth, fatigue, headache, dizziness upon standing (due to lowered blood pressure), sleep disturbances and skin reactions. The severity can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with postural tachycardia syndrome (POTS).

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I have been diagnosed with a specific type of POTS with high nerve activity.

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I have had symptoms when standing for 6 months without any other sudden illness causing it.

Exclusion Criteria

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

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

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I have had surgery on my neck.

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I have hardening of the artery in my neck.

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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 of 60 degrees upright tilt (delta voss), 2-3 hours after a dose of the treatment assigned for the previous period.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 30 min supine to after 15 min of 60 degrees upright tilt (delta voss), 2-3 hours after a dose of the treatment assigned for the previous period.

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 30 min supine to after 15 min of 60 degrees upright tilt (delta voss), 2-3 hours after a dose of the treatment assigned for the previous period. 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

Group I: Placebo then MoxonidineExperimental Treatment2 Interventions

After screening/baseline evaluations, patients will be discharged home on placebo identical to moxonidine once daily PO. After two weeks, the patients will be re-admitted for study testing while on placebo. At completion of this testing, patients will start taking moxonidine 0.2-0.4 mg/day PO to be continued at home. After two weeks, the patients will be re-admitted for study testing while on moxonidine.

Group II: Moxonidine then PlaceboExperimental Treatment2 Interventions

After screening/baseline evaluations, patients will be discharged home on moxonidine 0.2-0.4 mg/day PO. After two weeks, the patients will be re-admitted for study testing while on moxonidine. At completion of this testing, patients will start taking matching placebo once daily PO to be continued at home. After two, the patients will be re-admitted for study testing while on placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo oral tablet

2019

Completed Phase 4

~2430

0 / 7Eligibility criteria met