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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
10 patients will receive drug for 8 weeks
10 patients will receive drug for 8 weeks
Cedars-Sinai Medical Center
Los Angeles, California, United States
Blood Pressure
Mirabegron changes the average systolic BP in 24-hr ABPM recording
Time frame: 8 weeks
Syncope
Change of frequencies of syncope and presyncope
Time frame: 8 weeks
Hypotensive episode
Change of the hypotensive (systolic BP \< 90 mmHg) episodes during wake time using ABPM
Time frame: 8 weeks
Duke Activity Status Index Questionnaire
Change of functional capacity score as measured by the Duke Activity Status index questionnaire
Time frame: 8 weeks
EQ-5D-5L Questionnaire
Change of health related QOL score using a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Time frame: 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.
Time frame: 8 weeks
Overactive Bladder symptoms
Change in OAB symptoms as measured by the OAB-q SF
Time frame: 8 weeks
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