Using Mirabegron to Increase BP in Patients With POTS (NCT06133075) | Clinical Trial Compass
CompletedPhase 2
Using Mirabegron to Increase BP in Patients With POTS
United States20 participantsStarted 2023-12-22
Plain-language 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) who have a documented history of hypotension inadequately responsive to conventional treatments. The American Heart Association funds this study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.