Status:
COMPLETED
Using Mirabegron to Increase BP in Patients With POTS
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Postural Orthostatic Tachycardia Syndrome
Chronic Orthostatic Intolerance
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 capaci...
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 capaci...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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
Key Trial Info
Start Date :
December 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06133075
Start Date
December 22 2023
End Date
July 25 2025
Last Update
August 1 2025
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048