Beta-3 Enhanced Autonomic Therapy for POTS
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center
About this trial
The study will test the hypothesis that mirabegron is more effective than a placebo in alleviating postural orthostatic tachycardia (POTS) symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of a signed and dated informed consent form.
Male or female, age ≥ 18 years old.
Confirmed POTS diagnosis, which includes chronic (>3 months) orthostatic intolerance, an increase in heart rate (HR) of ≥30 beats per minute (bpm) without orthostatic hypotension (>20 mmHg drop of systolic BP) during orthostatic tests.
Disqualifiers
Patients who are pacemaker-dependent because the pacing artifacts will complicate skin sympathetic nerve activity (SKNA) analysis.
Clinically unstable (for example, acute myocardial infarction, decompensated heart failure, undergoing cancer chemotherapy, and other acute illnesses requiring hospitalization)
Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)18
Active thyrotoxicosis
Trial design
Design model
Parallel
Treatments tested in this trial
Mirabegron
DrugThis is a randomized placebo controlled double blind trial comparing mirabegron with placebo in treating POTS
Placebo
DrugMatching placebo
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: mirabegron armExperimental treatment 1 intervention
Group B: placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 treatmentSecondary outcomes
1
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 treatment2
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 treatment3
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 treatment4
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 treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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