Transdermal Vagal Stimulation for POTS



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:2/24/2019
Start Date:June 2013
End Date:December 2019

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Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome

Some patients experience high heart rates and symptoms of light-headedness, fatigue,
headache during standing despite well maintained blood pressure.

These patient are disabled and can't be in upright position for a longer time. The purpose of
this study is to test whether electrical stimulation of a nerve through a skin of the ear may
improve heart rate response and reduce disabling symptoms.

Background Postural Tachycardia Syndrome (POTS) is a syndrome characterized by disabling
symptoms of inadequate cerebral perfusion on assuming the upright posture, including
light-headedness, fatigue, palpitations, altered mentation, headache, nausea, presyncope, and
occasionally syncope.

POTS is characterized by an excessive increase in heart rate and exaggerated increase in
plasma catecholamine levels on standing in the absence of a blood pressure fall. These
disabling symptoms persist for more than six months.

Objective The objective of this study is to study the effect of vagal stimulation on heart
rate modulation during supine and upright posture as a treatment modality for patients with
POTS.

Inclusion Criteria:

- Non-smoking patients who qualify with the criteria of idiopathic postural tachycardia
syndrome will be studied. The criteria are:

1. an increase of heart rate of 30 beats/minute or an upright heart rate of >= 120
bpm, and

2. chronic problems of symptoms during upright posture for at least 6 month.

- Subjects must also be able to safely withdrawn from medications that influence heart
rate, blood pressure, and hormone levels that regulate blood pressure.

- The age limit is 18-75 years.

Exclusion Criteria:

- Patients that have other major medical problems, such as cancer or heart disease are
excluded because the influence of that diagnosis on the symptoms is not known.

- Pregnancy.
We found this trial at
1
site
Nashville, Tennessee 37232
Principal Investigator: Andre Diedrich, MD, PhD
Phone: 615-343-6499
?
mi
from
Nashville, TN
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