COMPLETED

Using Mirabegron to Increase BP in Patients With POTS

Conditions

Postural Orthostatic Tachycardia Syndrome Chronic Orthostatic Intolerance Syncope

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-22

Study Completion:2025-07-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06133075

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-22

Study Completion Date2025-07-25

Study Record Updates

Study Start Date2023-12-22

Study Completion Date2025-07-25

Terms related to this study

Additional Relevant MeSH Terms

Postural Orthostatic Tachycardia Syndrome
Chronic Orthostatic Intolerance
Syncope