Beta-3 Enhanced Autonomic Therapy for POTS | NCT07585513

Studies
Beta-3 Enhanced Autonomic Therapy for POTS

NCT07585513

Sponsor

Cedars-Sinai Medical Center

Status

Not yet recruiting

Last Update Posted

May 13, 2026Actual

Enrollment

36Estimated

Phase

Phase 2

Conditions

Postural Orthostatic Tachycardia Syndrome (POTS)

Interventions

Mirabegron
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
26BIPA1622610	Other Grant/Funding Number	The American Heart Association

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2026Estimated

Primary Completion Date

May 2028Estimated

Completion Date

May 2028Estimated

First Submitted Date

Apr 30, 2026

First Submission Date that Met QC Criteria

May 9, 2026

First Posted Date

May 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2026

Last Update Posted Date

May 13, 2026Actual

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mirabegron arm	Experimental	25 mg	Drug: Mirabegron
placebo arm	Placebo Comparator	matching placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mirabegron	Drug	This is a randomized placebo controlled double blind trial comparing mirabegron with placebo in treating POTS	mirabegron arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
Patients taking codeine, oxycodone, thioridazine, flecainide, propafenone, and digoxin. (see explanation below)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Peng-Sheng Chen, MD	Contact	310-967-2707		peng-sheng.chen@csmc.edu

IPD Sharing Statement Module

Plan to Share IPD

Description

AHA does not require IPD for studies supported by its grants.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D054971	Orthostatic Intolerance
D054969	Primary Dysautonomias
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases