Postural Orthostatic Tachycardia Syndrome (POTS)
Conditions
Brief summary
The study will test the hypothesis that mirabegron is more effective than a placebo in alleviating postural orthostatic tachycardia (POTS) symptoms.
Detailed description
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.
Interventions
DRUGMirabegron
This is a randomized placebo controlled double blind trial comparing mirabegron with placebo in treating POTS
DRUGPlacebo
Matching placebo
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of a signed and dated informed consent form. 2. Male or female, age ≥ 18 years old. 3. 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.
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study: 1. Patients who are pacemaker-dependent because the pacing artifacts will complicate skin sympathetic nerve activity (SKNA) analysis. 2. Clinically unstable (for example, acute myocardial infarction, decompensated heart failure, undergoing cancer chemotherapy, and other acute illnesses requiring hospitalization) 3. Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)18 4. Active thyrotoxicosis 5. Any experimental medication concomitantly or within 4 weeks of participation in the study 6. Currently participating in a different clinical trial 7. Severe renal impairment (CrCl \< 30 ml/min) 8. Hepatic disease (Child-Pugh Class C) 9. Prisoners 10. Pregnant 11. Breastfeeding 12. Cannot speak, write, or answer questions in English (Validated symptom questionnaires used in this study are available only in English.) 13. Does not have the capacity to consent 14. Patients who are known to be allergic to mirabegron or skin patch electrodes 15. Patients taking codeine, oxycodone, thioridazine, flecainide, propafenone, and digoxin. (see explanation below)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported frequencies of cardiac-related symptoms as recorded by the number of pushbutton events per day on the monitor. | At baseline and again immediately after the completion of drug treatment | Patients pushes button when there are symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Malmö POTS Symptom Score | At baseline and again immediately after the completion of drug treatment | 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) |
| EQ-5D-5L quality of life score | At baseline and again immediately after the completion of drug treatment | calculated score, best = 1, worst = -0.573 |
| Duke Activity Status Index | At baseline and again immediately after the completion of drug treatment | Scores range 0 to 58.2. The higher the score, the greater the individual's functional capacity. |
| Seattle Angina Questionnaire score | At baseline and again immediately after the completion of drug treatment | Measurement of Angina on a 0-100 scale. Higher score means better status and fewer symptoms. |
| OAB-q SF | At baseline and again immediately after the completion of drug treatment | Overactive bladder symptom measurements. best = 0, worst = 100. |
| PROMIS survey | At baseline and again immediately after the completion of drug treatment | PROMIS fatigue score range 30-80. Higher score = worse fatigue. |
| skin sympathetic nerve activity (SKNA) parameters | At baseline and again immediately after the completion of drug treatment | Average SKNA over 1 - minute windows, measured in μV. The higher the number, the higher the sympathetic nerve activity. |
Contacts
CONTACTPeng-Sheng Chen, MD
Outcome results
None listed