Using Mirabegron to Increase BP in Patients With POTS

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 American Heart Association funds this study.

Conditions

Postural Orthostatic Tachycardia Syndrome, Chronic Orthostatic Intolerance, Syncope

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Study Overview

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Study Details

Study overview

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.

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

Using Mirabegron to Increase BP in Patients With POTS

Condition
Postural Orthostatic Tachycardia Syndrome
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cedars-Sinai Medical Center,

Study Record Dates

2026-11-21