Using mirabegron to help increase blood pressure in patients with POTS

Using Mirabegron to Increase Blood Pressure in Patients With Postural Orthostatic Tachycardia Syndrome

This study is testing if the medication mirabegron can help people with POTS raise their blood pressure and feel better when other treatments haven't worked.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06133075 on ClinicalTrials.gov

What this trial studies

This pilot dose-finding study aims to evaluate the effects of mirabegron on increasing systolic blood pressure, preventing syncope and presyncope, and improving quality of life in patients with postural orthostatic tachycardia syndrome (POTS) who have not responded adequately to conventional treatments. Participants will undergo 24-hour ambulatory blood pressure monitoring and skin sympathetic nerve activity recording before and after an eight-week treatment period with mirabegron. The study will assess changes in symptoms and functional capacity through validated questionnaires and clinical evaluations. The research is funded by the American Heart Association.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a documented history of chronic orthostatic intolerance and syncope or presyncope unresponsive to conventional therapies.

Not a fit: Patients with other causes of syncope or those who have sustained tachyarrhythmias may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with POTS who experience hypotension and related symptoms.

How similar studies have performed: While this approach is novel in the context of POTS, similar studies using mirabegron for other conditions have shown promising results.

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

Where this trial is running

Los Angeles, California

• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)

Study contacts

• Study coordinator: Peng-Sheng Chen, MD

Conditions Postural Orthostatic Tachycardia Syndrome; Chronic Orthostatic Intolerance; Syncope