CompletedPhase 2
Using Mirabegron to Increase BP in Patients With POTS
Key facts
- Who runs it
- Cedars-Sinai Medical Center
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 20 people enrolled
- Started
- 22 Dec 2023
- Ended
- 25 Jul 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Mirabegron 50 MG
- Mirabegron 25 MG
- Record updated
- 8 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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 < 90 mmHg on 24-hr ABPM; Inadequate response to conventional therapies
Who cannot take part
- Any experimental medication concomitantly or within 4 weeks of participation in the study
- Patients with other potential etiologies of syncope; 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; Symptomatic bradycardia before pacemaker implantation
- Wolff Parkinson-White Syndrome
- Stroke within the past 6 months
- Any history of myocardial infarction
- 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
- Heart failure with either preserved or reduced ejection fraction
- Patients < 18 years old because mirabegron is not approved by FDA for use in children
- Active thyrotoxicosis
- Prisoners
Where in United States
- Cedars-Sinai Medical CenterLos Angeles, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- 50 mg groupExisting treatment, for comparison
Ten patients will receive 50 mg mirabegron for 8 weeks.
Treatment: Mirabegron 50 MG
- 25 mg groupExisting treatment, for comparison
Ten patients will receive 25 mg mirabegron for 8 weeks.
Treatment: Mirabegron 25 MG
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Using Mirabegron to Increase Blood Pressure in Patients With Postural Orthostatic Tachycardia Syndrome
- Record updated
- 8 April 2026