Postural Orthostatic Tachycardia SyndromePhase 2RAISE-BPNCT06133075
Using Mirabegron to Increase BP in Patients With POTS
A Phase 2 study testing Mirabegron 50 MG and Mirabegron 25 MG in people with Postural Orthostatic Tachycardia Syndrome and Chronic Orthostatic Intolerance, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This is a pilot dose-finding study to test the hypothesis that mirabegron increases systolic blood pressure (BP), prevents syncope/presyncope, and improves the quality of life (QOL), functional capacity, chest pain, and overactive bladder (OAB) symptoms in patients with postural orthostatic tachycardia syndrome (POTS)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome, Chronic Orthostatic Intolerance, Syncope
- What is being tested?
- Mirabegron 50 MG and Mirabegron 25 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2023to 25 Jul 2025
- Phase
- Phase 2
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 signed and dated informed consent form.
- Age > 18 years old.
- Documented history of chronic (> 3 months) of orthostatic intolerance.
- 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).
- At least one documented hypotensive episode with systolic BP < 90 mmHg on 24-hr ABPM.
- Inadequate response to conventional therapies.
Who cannot join
- Patients with other potential etiologies of syncope
- Sustained tachyarrhythmias other than sinus tachycardia. Specifically, patients with a diagnosis of atrial fibrillation, sustained (> 30 seconds) arrhythmias including paroxysmal supraventricular tachycardia, atrial flutter, ventricular tachycardia, ventricular fibrillation.
- Symptomatic bradycardia before pacemaker implantation.
- Heart failure with either preserved or reduced ejection fraction.
- Wolff Parkinson-White Syndrome.
- Stroke within the past 6 months.
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- Any history of myocardial infarction.
- Active thyrotoxicosis.
- Any experimental medication concomitantly or within 4 weeks of participation in the study.
- Patients < 18 years old because mirabegron is not approved by FDA for use in children.
- People with a history of allergy to ECG electrodes or adhesive tape.
- Patients with known contraindications or precautions to mirabegron.
- Hypertension
- Severe renal impairment (calculated CrCl < 30ml/min)
- Hepatic disease (Child-Pugh Class B)
- Pregnant or lactation
- Geriatric patients in long term care facilities
- Patients who are known to be allergic to mirabegron
- Patients taking drugs that are CYP2D6 substrates, such as midodrine. An extensive list can be found at the following website: https://drug-interactions.medicine.iu.edu/MainTable.aspx
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Using Mirabegron to Increase Blood Pressure in Patients With Postural Orthostatic Tachycardia Syndrome
This is a pilot dose-finding study to test the hypothesis that mirabegron increases systolic blood pressure (BP), prevents syncope/presyncope, and improves the quality of life (QOL), functional capacity, chest pain, and overactive bladder (OAB) symptoms in patients with postural orthostatic tachycardia syndrome (POTS) who have a documented history of hypotension inadequately responsive to conventional treatments. The American Heart Association funds this study.
Read the detailed description
This is a pilot dose-finding study to test the hypothesis that mirabegron increases systolic blood pressure (BP), prevents syncope/presyncope, and improves the quality of life (QOL), functional capacity, chest pain, and overactive bladder (OAB) symptoms in patients with postural orthostatic tachycardia syndrome (POTS) who have a documented history of hypotension inadequately responsive to conventional treatments. The investigators will perform 24-hour ambulatory blood pressure monitoring (ABPM) and ambulatory skin sympathetic nerve activity (SKNA) recording using a Bittium Faros electrocardiogram (ECG) monitor, assess the number of syncope and presyncope episodes and determine the symptoms using validated questionnaires at baseline. The patients will then be given mirabegron (either 25 mg once daily or 50 mg once daily) for eight weeks. Afterward, the patient will return to the clinic for clinical assessments, complete questionnaires, ABPM, and ambulatory SKNA recording while still on treatment. Mirabegron will be stopped when the data collection is complete. Because mirabegron has a long half-life, the investigators will schedule a video visit with the patient 12 weeks after beginning the treatment and inquire about the patient's symptoms. The investigators will repeat all pertinent questionnaires at that time.
- Being tested
- Mirabegron 50 MG, Mirabegron 25 MG
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron 50 MGDrug
Also called Myrbetriq
10 patients will receive drug for 8 weeks
Mirabegron 25 MGDrug
Also called Myrbetriq
10 patients will receive drug for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 50 mg group | Active comparator | Ten patients will receive 50 mg mirabegron for 8 weeks. Receives: Drug: Mirabegron 50 MG |
| 25 mg group | Active comparator | Ten patients will receive 25 mg mirabegron for 8 weeks. Receives: Drug: Mirabegron 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
A 24-hr ambulatory blood pressure monitor (ABPM) was used to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP). The participants' average SBP is the primary outcome. We also report the average DBP in this Table. Due to technical reasons, only 7 participants in 50 mg group and 8 participants in 25 mg group had ABPM available for analysis.
Measured: 8 weeks
Secondary outcomes (6)
Syncope
Change of frequencies of syncope and presyncope. Two of the initial 10 participants of each group exited the study early. So that we can compare the frequency of syncope at baseline with that at 8 weeks, we excluded those two patients from analysis. Therefore, we analyzed the 8 remaining participants in each group.
Measured: 8 weeks
Hypotensive Episode
Change of the hypotensive (systolic BP < 90 mmHg) episodes during wake time using ABPM, which is available in 7 participants in the 50 mg group and 8 in the 25 mg group. They were used to compare between baseline and 8 weeks. Patients without complete data were excluded from analysis.
Measured: 8 weeks
Duke Activity Status Index Questionnaire
Change of functional capacity score as measured by the Duke Activity Status index questionnaire. DASI (The Duke Activity Status Index): 0 to 58.2. The higher the score, the greater the individual's functional capacity.
Measured: 8 weeks
EQ-5D-5L Questionnaire
EuroQol 5-Dimension 5-Level, a questionnaire used to measure health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with five response levels each, designed to be more sensitive than earlier versions. The 5-component scale includes mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-5D-5L: calculated score best = 1, worst = -0.573; EQ-5D-5L YHT (Your Health Today) score is self-reported by the patient on a 0-100 scale, with 100 being the best.
Measured: 8 weeks
Seattle Angina Questionnaire (SAQ)
Change of QOL and symptoms of angina as measured by the SAQ based on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. Seattle Angina Questionnaire score on a 0-100 scale, with 100 being the best. SAQ subscales (physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale) all have a 0-100 scale, with 100 being the best. A total SAQ score can be calculated by averaging all domain scores.
Measured: 8 weeks
Overactive Bladder Symptoms
Overactive Bladder Questionnaire Short Form (OAB-q SF) measures change in Overactive Bladder (OAB) symptoms. The severity score: best = 0, worst = 100. OAB-Q SF Health-Related quality of life (HRQoL) assessments evaluate the impact of OAB symptoms on a patient's quality of life. HRQoL best = 100, worst = 0
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start22 Dec 2023
- Primary completion20 May 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postural Orthostatic Tachycardia SyndromeStudies 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
- Model description
- All patients will receive mirabegron 50 mg or 25 mg orally for 8 weeks to determine their effects on blood pressure.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
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
- NCT06133075
- Sponsor's protocol ID
- STUDY00002281
- Acronym
- RAISE-BP
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2023
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No