Trial Outcomes & Findings for Using Mirabegron to Increase BP in Patients With POTS (NCT NCT06133075)
NCT ID: NCT06133075
Last Updated: 2026-04-08
Results Overview
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.
COMPLETED
PHASE2
20 participants
8 weeks
2026-04-08
Participant Flow
Participant milestones
| Measure |
50 mg Group
Ten patients will receive 50 mg mirabegron for 8 weeks.
Mirabegron 50 MG: 10 patients will receive drug for 8 weeks
|
25 mg Group
Ten patients will receive 25 mg mirabegron for 8 weeks.
Mirabegron 25 MG: 10 patients will receive drug for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
50 mg Group
Ten patients will receive 50 mg mirabegron for 8 weeks.
Mirabegron 50 MG: 10 patients will receive drug for 8 weeks
|
25 mg Group
Ten patients will receive 25 mg mirabegron for 8 weeks.
Mirabegron 25 MG: 10 patients will receive drug for 8 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Using Mirabegron to Increase BP in Patients With POTS
Baseline characteristics by cohort
| Measure |
25 mg Group
n=10 Participants
Ten patients will receive 25 mg mirabegron for 8 weeks.
Mirabegron 25 MG: 10 patients will receive drug for 8 weeks
|
Total
n=20 Participants
Total of all reporting groups
|
50 mg Group
n=10 Participants
Ten patients will receive 50 mg mirabegron for 8 weeks.
Mirabegron 50 MG: 10 patients will receive drug for 8 weeks
|
|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 13 • n=527 Participants
|
38 years
STANDARD_DEVIATION 11 • n=1054 Participants
|
36 years
STANDARD_DEVIATION 10 • n=527 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=527 Participants
|
19 Participants
n=1054 Participants
|
10 Participants
n=527 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=527 Participants
|
1 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=527 Participants
|
3 Participants
n=1054 Participants
|
2 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=527 Participants
|
15 Participants
n=1054 Participants
|
6 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=527 Participants
|
2 Participants
n=1054 Participants
|
2 Participants
n=527 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=527 Participants
|
2 Participants
n=1054 Participants
|
2 Participants
n=527 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=527 Participants
|
15 Participants
n=1054 Participants
|
6 Participants
n=527 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=527 Participants
|
3 Participants
n=1054 Participants
|
2 Participants
n=527 Participants
|
|
Medications
Ivabradine
|
6 participants
n=527 Participants
|
10 participants
n=1054 Participants
|
4 participants
n=527 Participants
|
|
Medications
Cromolyn Sodium
|
2 participants
n=527 Participants
|
4 participants
n=1054 Participants
|
2 participants
n=527 Participants
|
|
Medications
Diphenhydramine
|
1 participants
n=527 Participants
|
2 participants
n=1054 Participants
|
1 participants
n=527 Participants
|
|
Medications
Famotidine
|
2 participants
n=527 Participants
|
5 participants
n=1054 Participants
|
3 participants
n=527 Participants
|
|
Medications
Midodrine
|
1 participants
n=527 Participants
|
2 participants
n=1054 Participants
|
1 participants
n=527 Participants
|
|
Medications
Verapamil
|
1 participants
n=527 Participants
|
1 participants
n=1054 Participants
|
0 participants
n=527 Participants
|
|
Medications
Atenolol
|
0 participants
n=527 Participants
|
1 participants
n=1054 Participants
|
1 participants
n=527 Participants
|
|
Medications
Bisoprolol
|
0 participants
n=527 Participants
|
1 participants
n=1054 Participants
|
1 participants
n=527 Participants
|
|
Medications
Citalopram
|
0 participants
n=527 Participants
|
1 participants
n=1054 Participants
|
1 participants
n=527 Participants
|
|
Medications
Fludrocortisone
|
0 participants
n=527 Participants
|
3 participants
n=1054 Participants
|
3 participants
n=527 Participants
|
|
Medications
Naloxone
|
0 participants
n=527 Participants
|
1 participants
n=1054 Participants
|
1 participants
n=527 Participants
|
|
Diagnoses
Alcohol Sensitive
|
3 participants
n=527 Participants
|
4 participants
n=1054 Participants
|
1 participants
n=527 Participants
|
|
Diagnoses
Chest Pain
|
4 participants
n=527 Participants
|
8 participants
n=1054 Participants
|
4 participants
n=527 Participants
|
|
Diagnoses
Dizziness
|
2 participants
n=527 Participants
|
7 participants
n=1054 Participants
|
5 participants
n=527 Participants
|
|
Diagnoses
Hypermobile Ehlers-Danlos Syndrome (hEDs)
|
6 participants
n=527 Participants
|
10 participants
n=1054 Participants
|
4 participants
n=527 Participants
|
|
Diagnoses
Mast Cell Activation Syndrome (MCAS)
|
6 participants
n=527 Participants
|
8 participants
n=1054 Participants
|
2 participants
n=527 Participants
|
|
Diagnoses
Palpitations
|
7 participants
n=527 Participants
|
13 participants
n=1054 Participants
|
6 participants
n=527 Participants
|
|
Diagnoses
Post-Prandial Hypotension
|
1 participants
n=527 Participants
|
1 participants
n=1054 Participants
|
0 participants
n=527 Participants
|
|
Diagnoses
Pre-Syncope
|
9 participants
n=527 Participants
|
18 participants
n=1054 Participants
|
9 participants
n=527 Participants
|
|
Diagnoses
Skin Sensitivity
|
4 participants
n=527 Participants
|
10 participants
n=1054 Participants
|
6 participants
n=527 Participants
|
|
Diagnoses
Syncope
|
8 participants
n=527 Participants
|
11 participants
n=1054 Participants
|
3 participants
n=527 Participants
|
|
Diagnoses
Hyperadrenergic POTS
|
3 participants
n=527 Participants
|
5 participants
n=1054 Participants
|
2 participants
n=527 Participants
|
|
Diagnoses
Mitral Valve Prolapse
|
0 participants
n=527 Participants
|
1 participants
n=1054 Participants
|
1 participants
n=527 Participants
|
|
Diagnoses
Paroxysmal Supraventricular Tachycardia (pSVT)
|
0 participants
n=527 Participants
|
1 participants
n=1054 Participants
|
1 participants
n=527 Participants
|
|
Average Sinus Rate
|
68 beats per minute
STANDARD_DEVIATION 10 • n=527 Participants
|
69 beats per minute
STANDARD_DEVIATION 9 • n=1054 Participants
|
69 beats per minute
STANDARD_DEVIATION 8 • n=527 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Out of 10 participants, only 7 participants in the 50 mg group and 8 participants in the 25 mg group had ABPM available for comparison at both baseline and at 8 weeks. Therefore, we only included them in the analysis to determine if there are significant changes of blood pressure from baseline to 8 weeks. Patients with incomplete data were not analyzed because we cannot compare baseline with 8 weeks.
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.
Outcome measures
| Measure |
50 mg Group
n=7 Participants
Ten patients will receive 50 mg mirabegron for 8 weeks.
Mirabegron 50 MG: 10 patients will receive drug for 8 weeks
|
25 mg Group
n=8 Participants
Ten patients will receive 25 mg mirabegron for 8 weeks.
Mirabegron 25 MG: 10 patients will receive drug for 8 weeks
|
|---|---|---|
|
Blood Pressure
Systolic Blood Pressure-Week 0
|
101 mmHg
Standard Deviation 7
|
107 mmHg
Standard Deviation 7
|
|
Blood Pressure
Diastolic Blood Pressure-Week 0
|
64 mmHg
Standard Deviation 4
|
68 mmHg
Standard Deviation 7
|
|
Blood Pressure
Systolic Blood Pressure-Week 8
|
101 mmHg
Standard Deviation 10
|
108 mmHg
Standard Deviation 6
|
|
Blood Pressure
Diastolic Blood Pressure-Week 8
|
66 mmHg
Standard Deviation 7
|
68 mmHg
Standard Deviation 6
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 2 participants in each group did not complete follow-up assessments at week 8. Therefore, only 8 participants in each group were analyzed at all timepoints.
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.
Outcome measures
| Measure |
50 mg Group
n=8 Participants
Ten patients will receive 50 mg mirabegron for 8 weeks.
Mirabegron 50 MG: 10 patients will receive drug for 8 weeks
|
25 mg Group
n=8 Participants
Ten patients will receive 25 mg mirabegron for 8 weeks.
Mirabegron 25 MG: 10 patients will receive drug for 8 weeks
|
|---|---|---|
|
Syncope
Baseline
|
0 average number of episodes
Standard Deviation 0
|
0 average number of episodes
Standard Deviation 0
|
|
Syncope
Week 8
|
0 average number of episodes
Standard Deviation 0
|
0 average number of episodes
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 2 participants in each group exited the study early. An additional participant in the 50 mg group did not complete ABPM at Week 8. Therefore, we analyzed the remaining 7 participants in the 50 mg group and 8 participants in the 25 mg group for all timepoints. The patients with incomplete data were excluded from the analysis.
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.
Outcome measures
| Measure |
50 mg Group
n=7 Participants
Ten patients will receive 50 mg mirabegron for 8 weeks.
Mirabegron 50 MG: 10 patients will receive drug for 8 weeks
|
25 mg Group
n=8 Participants
Ten patients will receive 25 mg mirabegron for 8 weeks.
Mirabegron 25 MG: 10 patients will receive drug for 8 weeks
|
|---|---|---|
|
Hypotensive Episode
Baseline
|
1.5 average number of episodes
Standard Deviation 1.6
|
1.9 average number of episodes
Standard Deviation 2.5
|
|
Hypotensive Episode
Week 8
|
1.8 average number of episodes
Standard Deviation 2.9
|
0.3 average number of episodes
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The purpose was to compare the scores between baseline and 8 weeks. Eight participants in each group had both baseline and 8 weeks data. They were analyzed. Two participants in each group exited the study early and were excluded from the analysis due to incomplete data.
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.
Outcome measures
| Measure |
50 mg Group
n=8 Participants
Ten patients will receive 50 mg mirabegron for 8 weeks.
Mirabegron 50 MG: 10 patients will receive drug for 8 weeks
|
25 mg Group
n=8 Participants
Ten patients will receive 25 mg mirabegron for 8 weeks.
Mirabegron 25 MG: 10 patients will receive drug for 8 weeks
|
|---|---|---|
|
Duke Activity Status Index Questionnaire
DASI Score-Week 8
|
30 score on a scale
Standard Deviation 16
|
9 score on a scale
Standard Deviation 10
|
|
Duke Activity Status Index Questionnaire
DASI Score-Week 0
|
24 score on a scale
Standard Deviation 17
|
12 score on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The purpose was to compare the scores between baseline and 8 weeks. Eight participants in each group had both baseline and 8 weeks data. They were analyzed. Two participants in each group exited the study early and were excluded from the analysis due to incomplete data.
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.
Outcome measures
| Measure |
50 mg Group
n=8 Participants
Ten patients will receive 50 mg mirabegron for 8 weeks.
Mirabegron 50 MG: 10 patients will receive drug for 8 weeks
|
25 mg Group
n=8 Participants
Ten patients will receive 25 mg mirabegron for 8 weeks.
Mirabegron 25 MG: 10 patients will receive drug for 8 weeks
|
|---|---|---|
|
EQ-5D-5L Questionnaire
Calculated Score-Week 0
|
0.70 score on a scale
Standard Deviation 0.21
|
0.18 score on a scale
Standard Deviation 0.30
|
|
EQ-5D-5L Questionnaire
Your Health Today Score-Week 0
|
59 score on a scale
Standard Deviation 24
|
34 score on a scale
Standard Deviation 14
|
|
EQ-5D-5L Questionnaire
Calculated Score-Week 8
|
0.73 score on a scale
Standard Deviation 0.26
|
0.27 score on a scale
Standard Deviation 0.33
|
|
EQ-5D-5L Questionnaire
Your Health Today Score-Week 8
|
64 score on a scale
Standard Deviation 19
|
47 score on a scale
Standard Deviation 17
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The purpose was to compare the scores between baseline and 8 weeks. Eight participants in each group had both baseline and 8 weeks data. They were analyzed. Two participants in each group exited the study early and were excluded from the analysis due to incomplete data.
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.
Outcome measures
| Measure |
50 mg Group
n=8 Participants
Ten patients will receive 50 mg mirabegron for 8 weeks.
Mirabegron 50 MG: 10 patients will receive drug for 8 weeks
|
25 mg Group
n=8 Participants
Ten patients will receive 25 mg mirabegron for 8 weeks.
Mirabegron 25 MG: 10 patients will receive drug for 8 weeks
|
|---|---|---|
|
Seattle Angina Questionnaire (SAQ)
Physical Limitation-Week 0
|
72 score on a scale
Standard Deviation 31
|
37 score on a scale
Standard Deviation 26
|
|
Seattle Angina Questionnaire (SAQ)
Angina Stability-Week 0
|
44 score on a scale
Standard Deviation 17
|
38 score on a scale
Standard Deviation 25
|
|
Seattle Angina Questionnaire (SAQ)
Angina Frequency-Week 0
|
86 score on a scale
Standard Deviation 12
|
69 score on a scale
Standard Deviation 9
|
|
Seattle Angina Questionnaire (SAQ)
Treatment Satisfaction-Week 0
|
87 score on a scale
Standard Deviation 24
|
55 score on a scale
Standard Deviation 19
|
|
Seattle Angina Questionnaire (SAQ)
QOL-Week 0
|
77 score on a scale
Standard Deviation 33
|
30 score on a scale
Standard Deviation 20
|
|
Seattle Angina Questionnaire (SAQ)
Summary-Week 0
|
78 score on a scale
Standard Deviation 23
|
45 score on a scale
Standard Deviation 14
|
|
Seattle Angina Questionnaire (SAQ)
Physical Limitation-Week 8
|
80 score on a scale
Standard Deviation 26
|
54 score on a scale
Standard Deviation 28
|
|
Seattle Angina Questionnaire (SAQ)
Angina Stability-Week 8
|
53 score on a scale
Standard Deviation 20
|
66 score on a scale
Standard Deviation 33
|
|
Seattle Angina Questionnaire (SAQ)
Angina Frequency-Week 8
|
93 score on a scale
Standard Deviation 11
|
70 score on a scale
Standard Deviation 20
|
|
Seattle Angina Questionnaire (SAQ)
Treatment Satisfaction-Week 8
|
92 score on a scale
Standard Deviation 14
|
82 score on a scale
Standard Deviation 15
|
|
Seattle Angina Questionnaire (SAQ)
QOL-Week 8
|
83 score on a scale
Standard Deviation 22
|
53 score on a scale
Standard Deviation 25
|
|
Seattle Angina Questionnaire (SAQ)
Summary-Week 8
|
85 score on a scale
Standard Deviation 19
|
59 score on a scale
Standard Deviation 20
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The purpose was to compare the scores between baseline and 8 weeks. Eight participants in each group had both baseline and 8 weeks data. They were analyzed. Two participants in each group exited the study early and were excluded from the analysis due to incomplete data.
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
Outcome measures
| Measure |
50 mg Group
n=8 Participants
Ten patients will receive 50 mg mirabegron for 8 weeks.
Mirabegron 50 MG: 10 patients will receive drug for 8 weeks
|
25 mg Group
n=8 Participants
Ten patients will receive 25 mg mirabegron for 8 weeks.
Mirabegron 25 MG: 10 patients will receive drug for 8 weeks
|
|---|---|---|
|
Overactive Bladder Symptoms
Severity Score-Week 0
|
25 score on a scale
Standard Deviation 24
|
50 score on a scale
Standard Deviation 23
|
|
Overactive Bladder Symptoms
HRQoL Score-Week 0
|
79 score on a scale
Standard Deviation 24
|
55 score on a scale
Standard Deviation 30
|
|
Overactive Bladder Symptoms
Severity Score-Week 8
|
15 score on a scale
Standard Deviation 17
|
18 score on a scale
Standard Deviation 11
|
|
Overactive Bladder Symptoms
HRQoL Score-Week 8
|
92 score on a scale
Standard Deviation 10
|
82 score on a scale
Standard Deviation 13
|
Adverse Events
50 mg Group
25 mg Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
50 mg Group
n=10 participants at risk
Ten patients will receive 50 mg mirabegron for 8 weeks.
Mirabegron 50 MG: 10 patients will receive drug for 8 weeks
|
25 mg Group
n=10 participants at risk
Ten patients will receive 25 mg mirabegron for 8 weeks.
Mirabegron 25 MG: 10 patients will receive drug for 8 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • 8 Weeks
|
10.0%
1/10 • 8 Weeks
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • 8 Weeks
|
20.0%
2/10 • 8 Weeks
|
|
Renal and urinary disorders
Urinary Discomfort
|
0.00%
0/10 • 8 Weeks
|
20.0%
2/10 • 8 Weeks
|
|
Eye disorders
Blurry Vision
|
10.0%
1/10 • 8 Weeks
|
0.00%
0/10 • 8 Weeks
|
|
Musculoskeletal and connective tissue disorders
Skin Irritation from Patch Electrode
|
10.0%
1/10 • 8 Weeks
|
10.0%
1/10 • 8 Weeks
|
|
Nervous system disorders
Palpitations
|
10.0%
1/10 • 8 Weeks
|
0.00%
0/10 • 8 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place