What is the Purpose of this Study?
The purpose of this study is to examine whether a drug called mirabegron reduces symptom frequency and improves quality of life in participants with postural orthostatic tachycardia syndrome (POTS). POTS is a condition in which rapid heart rate occurs upon standing, in addition to multiple associated symptoms. The study focuses on people who have POTS that has not been successfully treated with lifestyle modifications. Participants will be randomly assigned to receive either mirabegron 25 mg once daily or placebo (inactive substance).
Mirabegron is in a class of medications called beta-3 adrenergic agonists. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. It is approved by the U.S. Food and Drug Administration (FDA) to treat an overactive bladder, but its use in this study is considered experimental.
Eligibility
- 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.
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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)
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Randomized Placebo-Controlled Clinical Trial Evaluating Mirabegron's Effectiveness in Alleviating POTS Symptoms