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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent form.

• Age \> 18 years old.

• Documented history of chronic (\> 3 months) of orthostatic intolerance.

• Diagnosis of syncope or pre-syncope and documented intermittent hypotension unresponsive to conventional life-style modification therapy.

‣ A history of syncope (complete loss of consciousness) or presyncope (the sensation that one is about to pass out).

⁃ At least one documented hypotensive episode with systolic BP \< 90 mmHg on 24-hr ABPM.

⁃ Inadequate response to conventional therapies.

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Peng-Sheng Chen, MD
chenp3@cshs.org
310-967-2707
Backup
Anxhela Kote, BS
anxhela.kote@cshs.org
310-967-3854
Time Frame
Start Date: 2023-12-22
Estimated Completion Date: 2026-11-21
Participants
Target number of participants: 20
Treatments
Active_comparator: 50 mg group
Ten patients will receive 50 mg mirabegron for 8 weeks.
Active_comparator: 25 mg group
Ten patients will receive 25 mg mirabegron for 8 weeks.
Sponsors
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov

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