Using Mirabegron to Increase BP in Patients With POTS

Syncope Clinical Trial

— RAISE BP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133075
• Other study ID #: STUDY00002281
• Status: Recruiting
• Phase: Phase 2
• Start date: December 22, 2023
• Est. completion date: November 21, 2026

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: Peng-Sheng Chen, MD
• Phone: 310-967-2707
• Email: chenp3[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 investigators will perform 24-hour ambulatory blood pressure monitoring (ABPM) and ambulatory skin sympathetic nerve activity (SKNA) recording using a Bittium Faros electrocardiogram (ECG) monitor, assess the number of syncope and presyncope episodes and determine the symptoms using validated questionnaires at baseline. The patients will then be given mirabegron (either 25 mg once daily or 50 mg once daily) for eight weeks. Afterward, the patient will return to the clinic for clinical assessments, complete questionnaires, ABPM, and ambulatory SKNA recording while still on treatment. Mirabegron will be stopped when the data collection is complete. Because mirabegron has a long half-life, the investigators will schedule a video visit with the patient 12 weeks after beginning the treatment and inquire about the patient's symptoms. The investigators will repeat all pertinent questionnaires at that time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 21, 2026
• Est. primary completion date: November 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Orthostatic Intolerance
• Orthostatic Intolerance
• Postural Orthostatic Tachycardia Syndrome
• Syncope
• Syndrome
• Tachycardia

Intervention

Drug:
• Mirabegron 50 MG
10 patients will receive drug for 8 weeks
• Mirabegron 25 MG
10 patients will receive drug for 8 weeks

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Mirabegron changes the average systolic BP in 24-hr ABPM recording	8 weeks
Secondary	Syncope	Change of frequencies of syncope and presyncope	8 weeks
Secondary	Hypotensive episode	Change of the hypotensive (systolic BP < 90 mmHg) episodes during wake time using ABPM	8 weeks
Secondary	Duke Activity Status Index Questionnaire	Change of functional capacity score as measured by the Duke Activity Status index questionnaire	8 weeks
Secondary	EQ-5D-5L Questionnaire	Change of health related QOL score using a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression	8 weeks
Secondary	Seattle Angina Questionnaire (SAQ)	Change of QOL and symptoms of angina as measured by the SAQ based on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale.	8 weeks
Secondary	Overactive Bladder symptoms	Change in OAB symptoms as measured by the OAB-q SF	8 weeks