Beta-3 Enhanced Autonomic Therapy for POTS

NCT07585513 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: STUDY0000492926BIPA1622610
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postural Orthostatic Tachycardia Syndrome (POTS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Malmö POTS Symptom Score

  At baseline and again immediately after the completion of drug treatment

• EQ-5D-5L quality of life score

  At baseline and again immediately after the completion of drug treatment

• Duke Activity Status Index

  At baseline and again immediately after the completion of drug treatment

• Seattle Angina Questionnaire score

  At baseline and again immediately after the completion of drug treatment

• OAB-q SF

  At baseline and again immediately after the completion of drug treatment

Study Arms (2)

mirabegron arm

EXPERIMENTAL

25 mg

Drug: Mirabegron

placebo arm

PLACEBO COMPARATOR

matching placebo

Drug: Placebo

Interventions

Mirabegron DRUG

This is a randomized placebo controlled double blind trial comparing mirabegron with placebo in treating POTS

mirabegron arm

Placebo DRUG

Matching placebo

placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of a signed and dated informed consent form.
• Male or female, age ≥ 18 years old.
• 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.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Patients who are pacemaker-dependent because the pacing artifacts will complicate skin sympathetic nerve activity (SKNA) analysis.
• Clinically unstable (for example, acute myocardial infarction, decompensated heart failure, undergoing cancer chemotherapy, and other acute illnesses requiring hospitalization)
• Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)18
• Active thyrotoxicosis
• Any experimental medication concomitantly or within 4 weeks of participation in the study
• Currently participating in a different clinical trial
• Severe renal impairment (CrCl \< 30 ml/min)
• Hepatic disease (Child-Pugh Class C)
• Prisoners
• Pregnant
• Breastfeeding
• Cannot speak, write, or answer questions in English (Validated symptom questionnaires used in this study are available only in English.)
• Does not have the capacity to consent
• Patients who are known to be allergic to mirabegron or skin patch electrodes

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Peng-Sheng Chen, MD

CONTACT

310-967-2707; peng-sheng.chen@csmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician III

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share