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RAISE BP: Using Mirabegron to Increase BP in Patients With POTS

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06133075
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Mirabegron 50 MG
  • Drug: Mirabegron 25 MG
 Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
All patients will receive mirabegron 50 mg or 25 mg orally for 8 weeks to determine their effects on blood pressure.All patients will receive mirabegron 50 mg or 25 mg orally for 8 weeks to determine their effects on blood pressure.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Using Mirabegron to Increase Blood Pressure in Patients With Postural Orthostatic Tachycardia Syndrome
Anticipated Study Start Date :
Nov 22, 2023
Anticipated Primary Completion Date :
Nov 21, 2025
Anticipated Study Completion Date :
Nov 21, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 50 mg group

Ten patients will receive 50 mg mirabegron for 8 weeks.

Drug: Mirabegron 50 MG
10 patients will receive drug for 8 weeks
Other Names:
  • Myrbetriq

    		•
    Active Comparator: 25 mg group

    Ten patients will receive 25 mg mirabegron for 8 weeks.

    Drug: Mirabegron 25 MG
    10 patients will receive drug for 8 weeks
    Other Names:
  • Myrbetriq

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Blood Pressure [8 weeks]

      Mirabegron changes the average systolic BP in 24-hr ABPM recording

    Secondary Outcome Measures

    1. Syncope [8 weeks]

      Change of frequencies of syncope and presyncope

    2. Hypotensive episode [8 weeks]

      Change of the hypotensive (systolic BP < 90 mmHg) episodes during wake time using ABPM

    3. Duke Activity Status Index Questionnaire [8 weeks]

      Change of functional capacity score as measured by the Duke Activity Status index questionnaire

    4. EQ-5D-5L Questionnaire [8 weeks]

      Change of health related QOL score using a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression

    5. Seattle Angina Questionnaire (SAQ) [8 weeks]

      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.

    6. Overactive Bladder symptoms [8 weeks]

      Change in OAB symptoms as measured by the OAB-q SF

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

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

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

    7. Inadequate response to conventional therapies.

    Exclusion Criteria:

    1. Patients with other potential etiologies of syncope

    2. 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.

    3. Symptomatic bradycardia before pacemaker implantation.

    4. Heart failure with either preserved or reduced ejection fraction.

    5. Wolff Parkinson-White Syndrome.

    6. Stroke within the past 6 months.

    7. Any history of myocardial infarction.

    8. Active thyrotoxicosis.

    9. Any experimental medication concomitantly or within 4 weeks of participation in the study.

    10. Patients < 18 years old because mirabegron is not approved by FDA for use in children.

    11. People with a history of allergy to ECG electrodes or adhesive tape.

    12. Patients with known contraindications or precautions to mirabegron.

    13. Hypertension

    14. Severe renal impairment (calculated CrCl < 30ml/min)

    15. Hepatic disease (Child-Pugh Class B)

    16. Pregnant or lactation

    17. Geriatric patients in long term care facilities

    18. Patients who are known to be allergic to mirabegron

    19. 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

    20. Prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center Los Angeles California United States 90048

    Sponsors and Collaborators

    • Cedars-Sinai Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peng-Sheng Chen, Staff Physician, Cedars-Sinai Medical Center
    ClinicalTrials.gov Identifier:
    NCT06133075
    Other Study ID Numbers:
    • STUDY00002281
    First Posted:
    Nov 15, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Syncope
    Postural Orthostatic Tachycardia Syndrome
    Orthostatic Intolerance
    Tachycardia
    Syndrome
    Mirabegron

    Study Results

    No Results Posted as of Nov 18, 2023