Beta-3 Enhanced Autonomic Therapy for POTS (BEAT-POTS)

A Randomized Placebo-Controlled Clinical Trial Evaluating Mirabegron's Effectiveness in Alleviating POTS Symptoms

The study will test the hypothesis that mirabegron is more effective than a placebo in alleviating postural orthostatic tachycardia (POTS) symptoms.

Study Overview

• Status: Not yet recruiting
• Conditions: Postural Orthostatic Tachycardia Syndrome (POTS)
• Intervention / Treatment: Drug: Placebo; Drug: Mirabegron

Detailed Description

Participants will undergo 4 weeks of randomized treatment, with an optional 4-week extension, and a final safety follow-up visit 4 weeks after discontinuation (total participation up to 12 weeks). The investigators will perform skin sympathetic nerve activity (SKNA) recordings and assess self-reported symptom frequencies using the number of pushbutton events per day. The patients will also record symptoms in a daily diary. The investigators will assess quality of life (QOL) and overactive bladder (OAB) symptoms using validated questionnaires at baseline and after mirabegron treatment. The investigators will repeat the QOL questionnaires at 4 weeks and 8 weeks in those who choose to extend therapy.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Peng-Sheng Chen, MD; Phone Number: 310-967-2707; Email: peng-sheng.chen@csmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of a signed and dated informed consent form.
2. Male or female, age ≥ 18 years old.
3. Confirmed POTS diagnosis, which includes chronic (>3 months) orthostatic intolerance, an increase in heart rate (HR) of ≥30 beats per minute (bpm) without orthostatic hypotension (>20 mmHg drop of systolic BP) during orthostatic tests.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Patients who are pacemaker-dependent because the pacing artifacts will complicate skin sympathetic nerve activity (SKNA) analysis.
2. Clinically unstable (for example, acute myocardial infarction, decompensated heart failure, undergoing cancer chemotherapy, and other acute illnesses requiring hospitalization)
3. Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)18
4. Active thyrotoxicosis
5. Any experimental medication concomitantly or within 4 weeks of participation in the study
6. Currently participating in a different clinical trial
7. Severe renal impairment (CrCl < 30 ml/min)
8. Hepatic disease (Child-Pugh Class C)
9. Prisoners
10. Pregnant
11. Breastfeeding
12. Cannot speak, write, or answer questions in English (Validated symptom questionnaires used in this study are available only in English.)
13. Does not have the capacity to consent
14. Patients who are known to be allergic to mirabegron or skin patch electrodes
15. Patients taking codeine, oxycodone, thioridazine, flecainide, propafenone, and digoxin. (see explanation below)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mirabegron arm; 25 mg	Drug: Mirabegron; This is a randomized placebo controlled double blind trial comparing mirabegron with placebo in treating POTS
Placebo Comparator: placebo arm; matching placebo	Drug: Placebo; Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported frequencies of cardiac-related symptoms as recorded by the number of pushbutton events per day on the monitor.	Patients pushes button when there are symptoms	At baseline and again immediately after the completion of drug treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malmö POTS Symptom Score	It is a 12-item questionnaire in which each symptom is rated from 0 to 10 using a visual analogue scale. The total score range is 0 (no symptom) to 120 (maximal symptom)	At baseline and again immediately after the completion of drug treatment
EQ-5D-5L quality of life score	calculated score, best = 1, worst = -0.573	At baseline and again immediately after the completion of drug treatment
Duke Activity Status Index	Scores range 0 to 58.2. The higher the score, the greater the individual's functional capacity.	At baseline and again immediately after the completion of drug treatment
Seattle Angina Questionnaire score	Measurement of Angina on a 0-100 scale. Higher score means better status and fewer symptoms.	At baseline and again immediately after the completion of drug treatment
OAB-q SF	Overactive bladder symptom measurements. best = 0, worst = 100.	At baseline and again immediately after the completion of drug treatment
PROMIS survey	PROMIS fatigue score range 30-80. Higher score = worse fatigue.	At baseline and again immediately after the completion of drug treatment
skin sympathetic nerve activity (SKNA) parameters	Average SKNA over 1 - minute windows, measured in μV. The higher the number, the higher the sympathetic nerve activity.	At baseline and again immediately after the completion of drug treatment

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: May 9, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Orthostatic Intolerance; Postural Orthostatic Tachycardia Syndrome; mirabegron
• Other Study ID Numbers: STUDY00004929; 26BIPA1622610 (Other Grant/Funding Number: The American Heart Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: AHA does not require IPD for studies supported by its grants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes