Could a bladder drug help POTS patients stop fainting?
NCT ID NCT06133075
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small pilot study tested whether mirabegron, a drug typically used for overactive bladder, can raise blood pressure and reduce fainting in people with POTS who have low blood pressure that standard treatments didn't help. Twenty adults took either 25 mg or 50 mg of the drug for 8 weeks. Researchers measured blood pressure changes and tracked fainting episodes, but technical issues limited the data available for analysis.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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20 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Age \> 18 years old. 3. Documented history of chronic (\> 3 months) of orthostatic intolerance. 4. Diagnosis of syncope or pre-syncope and documented intermittent hypotension unresponsive to conventional life-style modification therapy. 1. A history of syncope (complete loss of consciousness) or presyncope (the sensation that one is about to pass out). 2. At least one documented hypotensive episode with systolic BP \< 90 mmHg on 24-hr ABPM. 3. Inadequate response to conventional therapies. Exclusion Criteria: 1. Patients with other potential etiologies of syncope 1. Sustained tachyarrhythmias other than sinus tachycardia. Specifically, patients with a diagnosis of atrial fibrillation, sustained (\> 30 seconds) arrhythmias including paroxysmal supraventricular tachycardia, atrial flutter, ventricular tachycardia, ventricular fibrillation. 2. Symptomatic bradycardia before pacemaker implantation. 2. Heart failure with either preserved or reduced ejection fraction. 3. Wolff Parkinson-White Syndrome. 4. Stroke within the past 6 months. 5. Any history of myocardial infarction. 6. Active thyrotoxicosis. 7. Any experimental medication concomitantly or within 4 weeks of participation in the study. 8. Patients \< 18 years old because mirabegron is not approved by FDA for use in children. 9. People with a history of allergy to ECG electrodes or adhesive tape. 10. Patients with known contraindications or precautions to mirabegron. 1. Hypertension 2. Severe renal impairment (calculated CrCl \< 30ml/min) 3. Hepatic disease (Child-Pugh Class B) 4. Pregnant or lactation 5. Geriatric patients in long term care facilities 6. Patients who are known to be allergic to mirabegron 7. Patients taking drugs that are CYP2D6 substrates, such as midodrine. An extensive list can be found at the following website: https://drug-interactions.medicine.iu.edu/MainTable.aspx 11. Prisoners
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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