Using Mirabegron to Increase BP in Patients With POTS

Last updated: February 10, 2025
Sponsor: Cedars-Sinai Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Heart Disease

Low Blood Pressure (Hypotension)

Heart Defect

Treatment

Mirabegron 50 MG

Mirabegron 25 MG

Clinical Study ID

NCT06133075
STUDY00002281
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 hypotensionunresponsive to conventional life-style modification therapy.

  5. A history of syncope (complete loss of consciousness) or presyncope (thesensation that one is about to pass out).

  6. At least one documented hypotensive episode with systolic BP < 90 mmHg on 24-hrABPM.

  7. Inadequate response to conventional therapies.

Exclusion

Exclusion Criteria:

  1. Patients with other potential etiologies of syncope

  2. Sustained tachyarrhythmias other than sinus tachycardia. Specifically, patientswith a diagnosis of atrial fibrillation, sustained (> 30 seconds) arrhythmiasincluding paroxysmal supraventricular tachycardia, atrial flutter, ventriculartachycardia, ventricular fibrillation.

  3. Symptomatic bradycardia before pacemaker implantation.

  4. Heart failure with either preserved or reduced ejection fraction.

  5. Wolff Parkinson-White Syndrome.

  6. Stroke within the past 6 months.

  7. Any history of myocardial infarction.

  8. Active thyrotoxicosis.

  9. Any experimental medication concomitantly or within 4 weeks of participation in thestudy.

  10. Patients < 18 years old because mirabegron is not approved by FDA for use inchildren.

  11. People with a history of allergy to ECG electrodes or adhesive tape.

  12. Patients with known contraindications or precautions to mirabegron.

  13. Hypertension

  14. Severe renal impairment (calculated CrCl < 30ml/min)

  15. Hepatic disease (Child-Pugh Class B)

  16. Pregnant or lactation

  17. Geriatric patients in long term care facilities

  18. Patients who are known to be allergic to mirabegron

  19. Patients taking drugs that are CYP2D6 substrates, such as midodrine. Anextensive list can be found at the following website:https://drug-interactions.medicine.iu.edu/MainTable.aspx

  20. Prisoners

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Mirabegron 50 MG
Phase: 2
Study Start date:
December 22, 2023
Estimated Completion Date:
November 21, 2026

Study 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 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.

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.