Phase 2
N=20
Using Mirabegron to Increase BP in Patients With POTS
Postural Orthostatic Tachycardia Syndrome · Chronic Orthostatic Intolerance · Syncope
Bottom Line
View on ClinicalTrials.gov: NCT06133075 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Blood Pressure — 101; 107; 64; 68 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mirabegron 50 MG (Drug); Mirabegron 25 MG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Pressure |
101; 107; 64; 68; 101; 108 | — |
| SECONDARY Syncope |
0; 0; 0; 0 | — |
| SECONDARY Hypotensive Episode |
1.5; 1.9; 1.8; 0.3 | — |
| SECONDARY Duke Activity Status Index Questionnaire |
24; 12; 30; 9 | — |
| SECONDARY EQ-5D-5L Questionnaire |
0.70; 0.18; 59; 34; 0.73; 0.27 | — |
| SECONDARY Seattle Angina Questionnaire (SAQ) |
72; 37; 44; 38; 86; 69 | — |
| SECONDARY Overactive Bladder Symptoms |
25; 50; 79; 55; 15; 18 | — |
Summary
This is a pilot dose-finding study to test the hypothesis that mirabegron increases systolic blood pressure (BP), prevents syncope/presyncope, and improves the quality of life (QOL), functional capacity, chest pain, and overactive bladder (OAB) symptoms in patients with postural orthostatic tachycardia syndrome (POTS) who have a documented history of hypotension inadequately responsive to conventional treatments. The American Heart Association funds this study.
Eligibility Criteria
Inclusion Criteria
- Provision of signed and dated informed consent form.
- Age > 18 years old.
- Documented history of chronic (> 3 months) of orthostatic intolerance.
- Diagnosis of syncope or pre-syncope and documented intermittent hypotension unresponsive to conventional life-style modification therapy.
- A history of syncope (complete loss of consciousness) or presyncope (the sensation that one is about to pass out).
- At least one documented hypotensive episode with systolic BP 30 seconds) arrhythmias including paroxysmal supraventricular tachycardia, atrial flutter, ventricular tachycardia, ventricular fibrillation.
- Symptomatic bradycardia before pacemaker implantation.
- Heart failure with either preserved or reduced ejection fraction.
- Wolff Parkinson-White Syndrome.
- Stroke within the past 6 months.
- Any history of myocardial infarction.
- Active thyrotoxicosis.
- Any experimental medication concomitantly or within 4 weeks of participation in the study.
- Patients < 18 years old because mirabegron is not approved by FDA for use in children.
- People with a history of allergy to ECG electrodes or adhesive tape.
- Patients with known contraindications or precautions to mirabegron.
- Hypertension
- Severe renal impairment (calculated CrCl < 30ml/min)
- Hepatic disease (Child-Pugh Class B)
- Pregnant or lactation
- Geriatric patients in long term care facilities
- Patients who are known to be allergic to mirabegron
- 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
- Prisoners
Data sourced from ClinicalTrials.gov (NCT06133075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.