Using Mirabegron to Increase BP in Patients With POTS

NCT06133075 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY00002281
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postural Orthostatic Tachycardia Syndrome; Chronic Orthostatic Intolerance; Syncope

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  A 24-hr ambulatory blood pressure monitor (ABPM) was used to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP). The participants' average SBP is the primary outcome. We also report the average DBP in this Table. Due to technical reasons, only 7 participants in 50 mg group and 8 participants in 25 mg group had ABPM available for analysis.

  8 weeks

Secondary Outcomes (6)

• Syncope

  8 weeks

• Hypotensive Episode

  8 weeks

• Duke Activity Status Index Questionnaire

  8 weeks

• EQ-5D-5L Questionnaire

  8 weeks

• Seattle Angina Questionnaire (SAQ)

  8 weeks

Study Arms (2)

50 mg group

ACTIVE COMPARATOR

Ten patients will receive 50 mg mirabegron for 8 weeks.

Drug: Mirabegron 50 MG

25 mg group

ACTIVE COMPARATOR

Ten patients will receive 25 mg mirabegron for 8 weeks.

Drug: Mirabegron 25 MG

Interventions

Mirabegron 50 MG DRUG

10 patients will receive drug for 8 weeks

Also known as: Myrbetriq

50 mg group

Mirabegron 25 MG DRUG

10 patients will receive drug for 8 weeks

Also known as: Myrbetriq

25 mg group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with other potential etiologies of syncope
• 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.
• Symptomatic bradycardia before pacemaker implantation.
• Heart failure with either preserved or reduced ejection fraction.
• Wolff Parkinson-White Syndrome.
• Stroke within the past 6 months.
• Any history of myocardial infarction.
• Active thyrotoxicosis.
• Any experimental medication concomitantly or within 4 weeks of participation in the study.
• Patients \< 18 years old because mirabegron is not approved by FDA for use in children.
• People with a history of allergy to ECG electrodes or adhesive tape.
• Patients with known contraindications or precautions to mirabegron.
• Hypertension
• Severe renal impairment (calculated CrCl \< 30ml/min)
• Hepatic disease (Child-Pugh Class B)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Syncope

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Peng-Sheng Chen, MD
• Organization: Cedars-Sinai Medical Center

Peng-Sheng.Chen@cshs.org

310-967-2707

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Model Details: All patients will receive mirabegron 50 mg or 25 mg orally for 8 weeks to determine their effects on blood pressure.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 15, 2023
• Study Start: December 22, 2023
• Primary Completion: May 20, 2025
• Study Completion: July 25, 2025
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)