Using Mirabegron to Increase BP in Patients With POTS

Launched by CEDARS-SINAI MEDICAL CENTER · Nov 9, 2023

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ClinConnect Summary

This clinical trial is studying a medication called mirabegron to see if it can help increase blood pressure and improve symptoms in patients with Postural Orthostatic Tachycardia Syndrome (POTS). POTS can cause people to feel dizzy or faint when they stand up due to low blood pressure, and this study aims to find out if mirabegron can prevent these symptoms, enhance quality of life, and help with related issues like chest pain and overactive bladder. The trial is currently recruiting participants who are 18 years or older, have a history of feeling faint or dizzy when standing, and have not found relief from other treatments.

Eligible participants will need to sign consent forms and meet certain health criteria, such as having experienced low blood pressure episodes. Throughout the trial, participants can expect to take mirabegron and be monitored for any improvements in their symptoms and overall well-being. It’s important to note that certain medical conditions or medications may exclude someone from participating, so it's best to discuss any concerns with a healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Provision of signed and dated informed consent form.
• • 2. Age \> 18 years old.
• • 3. Documented history of chronic (\> 3 months) of orthostatic intolerance.
• • 4. Diagnosis of syncope or pre-syncope and documented intermittent hypotension unresponsive to conventional life-style modification therapy.
• • 1. A history of syncope (complete loss of consciousness) or presyncope (the sensation that one is about to pass out).
• • 2. At least one documented hypotensive episode with systolic BP \< 90 mmHg on 24-hr ABPM.
• • 3. Inadequate response to conventional therapies.
• Exclusion Criteria:
• • 1. Patients with other potential etiologies of syncope
• • 1. 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.
• • 2. Symptomatic bradycardia before pacemaker implantation.
• • 2. Heart failure with either preserved or reduced ejection fraction.
• • 3. Wolff Parkinson-White Syndrome.
• • 4. Stroke within the past 6 months.
• • 5. Any history of myocardial infarction.
• • 6. Active thyrotoxicosis.
• • 7. Any experimental medication concomitantly or within 4 weeks of participation in the study.
• • 8. Patients \< 18 years old because mirabegron is not approved by FDA for use in children.
• • 9. People with a history of allergy to ECG electrodes or adhesive tape.
• • 10. Patients with known contraindications or precautions to mirabegron.
• • 1. Hypertension
• • 2. Severe renal impairment (calculated CrCl \< 30ml/min)
• • 3. Hepatic disease (Child-Pugh Class B)
• • 4. Pregnant or lactation
• • 5. Geriatric patients in long term care facilities
• • 6. Patients who are known to be allergic to mirabegron
• • 7. 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
• • 11. Prisoners