Postural Orthostatic Tachycardia Syndrome (POTS)Phase 2BEAT-POTSNCT07585513
Beta-3 Enhanced Autonomic Therapy for POTS
A Phase 2 study testing Mirabegron in people with Postural Orthostatic Tachycardia Syndrome (POTS), run by Cedars-Sinai Medical Center.
Trial summary
The study will test the hypothesis that mirabegron is more effective than a placebo in alleviating postural orthostatic tachycardia (POTS) symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome (POTS)
- What is being tested?
- Mirabegron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- May 2026to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Mirabegron, Placebo
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
This is a randomized placebo controlled double blind trial comparing mirabegron with placebo in treating POTS
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| mirabegron arm | Experimental | 25 mg Receives: Drug: Mirabegron |
| placebo arm | Placebo comparator | matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and again immediately after the completion of drug treatment
Secondary outcomes (7)
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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: At baseline and again immediately after the completion of drug treatment
OAB-q SF
Overactive bladder symptom measurements. best = 0, worst = 100.
Measured: At baseline and again immediately after the completion of drug treatment
PROMIS survey
PROMIS fatigue score range 30-80. Higher score = worse fatigue.
Measured: 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.
Measured: At baseline and again immediately after the completion of drug treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Orthostatic Tachycardia Syndrome (POTS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng-Sheng Chen, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585513
- Sponsor's protocol ID
- STUDY00004929
- Other IDs
- 26BIPA1622610
- Acronym
- BEAT-POTS
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: AHA does not require IPD for studies supported by its grants.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Clinical Trial Evaluating Mirabegron's Effectiveness in Alleviating POTS Symptoms
- ClinicalTrials.gov ID
- NCT07585513
- Acronym / sponsor ID
- BEAT-POTS / STUDY00004929
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mirabegron arm | Experimental | Drug: Mirabegron25 mg |
| placebo arm | Placebo comparator | Drug: Placebomatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirabegronThis is a randomized placebo controlled double blind trial comparing mirabegron with placebo in treating POTS | Drug | mirabegron arm |
| PlaceboMatching placebo | Drug | placebo arm |
Primary outcome
Self-reported frequencies of cardiac-related symptoms as recorded by the number of pushbutton events per day on the monitor.
Time frame: At baseline and again immediately after the completion of drug treatment
Patients pushes button when there are symptoms
7 secondary outcomes
Malmö POTS Symptom Score
Time frame: At baseline and again immediately after the completion of drug treatment
EQ-5D-5L quality of life score
Time frame: At baseline and again immediately after the completion of drug treatment
Duke Activity Status Index
Time frame: At baseline and again immediately after the completion of drug treatment
Seattle Angina Questionnaire score
Time frame: At baseline and again immediately after the completion of drug treatment
OAB-q SF
Time frame: At baseline and again immediately after the completion of drug treatment
PROMIS survey
Time frame: At baseline and again immediately after the completion of drug treatment
skin sympathetic nerve activity (SKNA) parameters
Time frame: At baseline and again immediately after the completion of drug treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. AHA does not require IPD for studies supported by its grants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirabegron in people with Postural Orthostatic Tachycardia Syndrome (POTS), run by Cedars-Sinai Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng-Sheng Chen, MD (310-967-2707, peng-sheng.chen@csmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported frequencies of cardiac-related symptoms as recorded by the number of pushbutton events per day on the monitor. (time frame: At baseline and again immediately after the completion of drug treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.