Overview

Using Mirabegron to Increase BP in Patients With POTS

Status:
Recruiting

Trial end date:
2026-11-21

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Cedars-Sinai Medical Center

Treatments:

Mirabegron

Criteria

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