Mirabegron to Increase Blood Pressure in Postural Orthostatic Tachycardia Syndrome

What is the Purpose of this Study?

The purpose of this study is to evaluate whether a drug called mirabegron increases systolic blood pressure (BP), prevents syncope (fainting)/pre-syncope, and improves the quality of life and overactive bladder symptoms in patients with postural orthostatic tachycardia syndrome (POTS). The study focuses on people who have POTS and a history of hypotension (low blood pressure) that has not been successfully treated with medications or changes to daily lifestyle habits. Participants will be randomly assigned to 1 of 2 groups. Group 1 will receive 25 mg/day of mirabegron; Group 2 will receive 50 mg/day of mirabegron. Other procedures include blood pressure monitoring, skin sympathetic nerve activity recording using an electrocardiogram monitor, and completion of questionnaires. Mirabegron is in a class of medications called beta-3 adrenergic agonists. Mirabegron is approved by the U.S. Food and Drug Administration (FDA) for overactive bladder in adults, but its use in this study is investigational.

Eligibility

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.

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

Show less

Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Using Mirabegron to Increase Blood Pressure in Patients with Dysautonomia

Study Details

Disease Type/Condition

Other

Principal Investigator

Chen, Peng-Sheng

Age Group

Adult

Phase

III

IRB Number

STUDY00002281

ClinicalTrials.gov ID

NCT06133075

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org