The study will test the hypothesis that mirabegron is more effective than a placebo in alleviating postural orthostatic tachycardia (POTS) symptoms.
Participants will undergo 4 weeks of randomized treatment, with an optional 4-week extension, and a final safety follow-up visit 4 weeks after discontinuation (total participation up to 12 weeks). The investigators will perform skin sympathetic nerve activity (SKNA) recordings and assess self-reported symptom frequencies using the number of pushbutton events per day. The patients will also record symptoms in a daily diary. The investigators will assess quality of life (QOL) and overactive bladder (OAB) symptoms using validated questionnaires at baseline and after mirabegron treatment. The investigators will repeat the QOL questionnaires at 4 weeks and 8 weeks in those who choose to extend therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
This is a randomized placebo controlled double blind trial comparing mirabegron with placebo in treating POTS
Matching placebo
Self-reported frequencies of cardiac-related symptoms as recorded by the number of pushbutton events per day on the monitor.
Patients pushes button when there are symptoms
Time frame: At baseline and again immediately after the completion of drug treatment
Malmö POTS Symptom Score
It is a 12-item questionnaire in which each symptom is rated from 0 to 10 using a visual analogue scale. The total score range is 0 (no symptom) to 120 (maximal symptom)
Time frame: At baseline and again immediately after the completion of drug treatment
EQ-5D-5L quality of life score
calculated score, best = 1, worst = -0.573
Time frame: At baseline and again immediately after the completion of drug treatment
Duke Activity Status Index
Scores range 0 to 58.2. The higher the score, the greater the individual's functional capacity.
Time frame: At baseline and again immediately after the completion of drug treatment
Seattle Angina Questionnaire score
Measurement of Angina on a 0-100 scale. Higher score means better status and fewer symptoms.
Time frame: At baseline and again immediately after the completion of drug treatment
OAB-q SF
Overactive bladder symptom measurements. best = 0, worst = 100.
Time frame: At baseline and again immediately after the completion of drug treatment
PROMIS survey
PROMIS fatigue score range 30-80. Higher score = worse fatigue.
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Time frame: At baseline and again immediately after the completion of drug treatment
skin sympathetic nerve activity (SKNA) parameters
Average SKNA over 1 - minute windows, measured in μV. The higher the number, the higher the sympathetic nerve activity.
Time frame: At baseline and again immediately after the completion of drug treatment