Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Postural Tachycardia Syndrome
Type
Interventional
Phase
Early Phase 1
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: randomized, double blind, crossover designMasking: Double (Participant, Investigator)Masking Description: Vanderbilt's Investigational Pharmacy will randomly assign participants to the moxonidine/placebo or placebo/moxonidine arm of the study. They will also provide the active drug and matching placebo. The medication distribution list will be kept by a dedicated person not involved in the study.Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 55 years
Gender
Only males

Description

Patients with POTS experience symptoms and an increase in heart rate?30 beats/min with standing in the absence of orthostatic hypotension. As a result of considerable functional impairment, individuals with POTS are often unable to attend school or work. There is agreement that POTS is a heterogeneo...

Patients with POTS experience symptoms and an increase in heart rate?30 beats/min with standing in the absence of orthostatic hypotension. As a result of considerable functional impairment, individuals with POTS are often unable to attend school or work. There is agreement that POTS is a heterogeneous disorder with multiple overlapping pathophysiologies proposed to underlie the clinical phenotype of patients. It would be important to define the underlying pathophysiological mechanisms in an individual patient to design optimal therapy. Our overarching hypothesis is that there is a subset of POTS patients (psPOTS) with a central sympathetic activation as the primary pathophysiology. We have characterized these patients by an increase in muscle sympathetic nerve activity (MSNA, a reflection of central sympathetic outflow) even at rest. In this project, we will focus on the role of primary sympathetic activation in the pathogenesis of POTS. Direct neural recordings of sympathetic activity, central sympathetic inhibition and extensive autonomic phenotyping will enable us to identify and correct the primary pathophysiology to optimally benefit psPOTS patients. This is a mechanistic study, designed to assess the effects of 4 weeks of central sympatholysis with moxonidine on orthostatic tachycardia and symptoms (Specific Aim 1), hypovolemia (Specific Aim 2) and central and peripheral baroreflex properties (Specific Aim 3) in a randomized, crossover design with POTS patients having elevated resting sympathetic nerve activity.

Tracking Information

NCT #
NCT04140721
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: André Diedrich, MD Vanderbilt University Medical Center