Using Mirabegron to Increase BP in Patients With POTS

Completed · Phase 2

Conditions studied: Postural Orthostatic Tachycardia Syndrome, Chronic Orthostatic Intolerance, Syncope

In brief

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.

Key facts

Study ID

NCT06133075

Run by

Cedars-Sinai Medical Center

People needed

20

Starts

2023-12-22

Expected to finish

2025-07-25

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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