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Mirabegron for Postural Orthostatic Tachycardia Syndrome (RAISE BP Trial)

Phase 2
Recruiting
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of syncope or pre-syncope and documented intermittent hypotension unresponsive to conventional life-style modification therapy
A history of syncope (complete loss of consciousness) or presyncope (the sensation that one is about to pass out)
Must not have
Sustained tachyarrhythmias other than sinus tachycardia
Symptomatic bradycardia before pacemaker implantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a drug can improve BP, syncope, QOL, chest pain, and OAB in POTS patients, funded by the American Heart Association.

Who is the study for?
This trial is for adults over 18 with Postural Orthostatic Tachycardia Syndrome (POTS) who often feel faint or have rapid heartbeats due to low blood pressure and haven't found relief with standard treatments. It's not for those allergic to Mirabegron, pregnant, breastfeeding, with severe kidney issues, certain heart conditions, recent stroke or heart attack, active thyroid problems, or taking specific drugs.
What is being tested?
The study tests if Mirabegron can help raise blood pressure and improve life quality in POTS patients by preventing fainting spells and reducing chest pain and bladder symptoms. Two doses of Mirabegron (25 MG & 50 MG) are being compared to find the most effective one.
What are the potential side effects?
Mirabegron may cause increased blood pressure, urinary tract infections (UTI), headaches, dizziness, nausea, diarrhea constipation or joint pain. Some people might also experience a fast heartbeat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have fainting spells or near-fainting due to low blood pressure not improved by lifestyle changes.
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I have a history of fainting or almost fainting.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a fast heart rate that is not due to sinus tachycardia.
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I experienced slow heartbeats before getting a pacemaker.
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I have not had a stroke in the last 6 months.
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I have had a heart attack before.
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I have an overactive thyroid.
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I am 18 years old or older.
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I cannot take mirabegron due to health risks.
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My liver function is moderately impaired.
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I have heart failure, regardless of my heart's pumping ability.
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I have Wolff-Parkinson-White Syndrome.
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I am a senior living in a long-term care facility.
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My kidney function is severely impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood Pressure
Secondary study objectives
Duke Activity Status Index Questionnaire
EQ-5D-5L Questionnaire
Hypotensive episode
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: 25 mg groupActive Control1 Intervention
Ten patients will receive 25 mg mirabegron for 8 weeks.
Group II: 50 mg groupActive Control1 Intervention
Ten patients will receive 50 mg mirabegron for 8 weeks.

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Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
512 Previous Clinical Trials
163,344 Total Patients Enrolled
~10 spots leftby Nov 2025
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