Using Mirabegron to Control Arrhythmia-1 (MACH-1)

To evaluate mirabegron's effect on ventricular arrhythmia control. The study will be conducted in ambulatory patients with ventricular tachycardia (VT), organic heart diseases, and an implantable cardioverter-defibrillator (ICD). The investigators will perform a pilot study involving 20 patients. Each will receive 50 mg of mirabegron. All will have neuECG recordings made before and 2 months after mirabegron. The data will be analyzed to test the proposed hypothesis.

Study Overview

• Status: Not yet recruiting
• Conditions: Ventricular Arrhythmias and Cardiac Arrest
• Intervention / Treatment: Drug: Mirabegron

Detailed Description

Objectives:

Primary objective: To evaluate if mirabegron can reduce the VT burden. Secondary objective: To test the hypothesis that mirabegron can reduce the average skin sympathetic nerve activity (aSKNA).

Endpoints: The primary endpoint is the burden of VT detected by ICD. The secondary endpoint is the average skin sympathetic nerve activity, symptoms, and quality of life (QOL) questionnaires.

Study Population: This is a pilot study in patients with an ICD and, on average, > 2 episodes of VT per month over the past 2 months despite guideline-recommended medical therapy (GRMT).

Phase: Phase 2.

Description of Sites/Facilities Enrolling Participants: The investigators will enroll patients in the cardiac device clinic at the Smidt Heart Institute, Cedars-Sinai Medical Center. Dr. Ashkan Ehdaie (co-investigator) directs the clinic, which routinely follows up on patients with ICDs.

Description of Study Intervention: The investigators will give the patients 50 mg/day of mirabegron orally for three months.

Study Duration: One-year.

Participant Duration: Approximately three months. The primary endpoint takes 2 months to complete. The investigators will call the patient at 3 months to determine if there are any complications. The patient will then exit the study.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Peng-Sheng Chen, MD; Phone Number: 310-967-2707; Email: peng-sheng.chen@csmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• In order to be eligible to participate in this study, an individual must meet all the following criteria:

  1. Provision of signed and dated informed consent form.
  2. Age > 18 years old.

  3. Documented VT on ICD.

     1. with > 2 episodes of VT per month (on average) over the past 2 months.
     2. despite guideline-recommended medical therapy (GRMT).

Exclusion Criteria:

• An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Patients who are pacemaker-dependent because the pacing artifacts will complicate skin sympathetic nerve activity (SKNA) analysis.
  2. Clinically unstable (for example, acute myocardial infarction, decompensated heart failure, undergoing cancer chemotherapy, and other acute illness requiring hospitalization)
  3. Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)25
  4. Active thyrotoxicosis
  5. Any experimental medication concomitantly or within 4 weeks of participation in the study
  6. Currently participating in a different clinical trial
  7. Severe renal impairment (CrCl < 30 ml/min)
  8. Hepatic disease (Child-Pugh Class C)
  9. Pregnant
  10. Breastfeeding
  11. Cannot speak, write, and answer questions in English
  12. Does not have the capacity to consent
  13. Severe renal impairment (CrCl < 30 ml/min)
  14. Hepatic disease (Child-Pugh Class C)
  15. Pregnant
  16. Breastfeeding
  17. Cannot speak, write, and answer questions in English
  18. Does not have the capacity to consent
  19. Patients who are known to be allergic to mirabegron or skin patch electrodes
  20. Patients taking codeine, oxycodone, thioridazine, flecainide, propafenone, and digoxin. (see explanation below)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mirabegron; The investigators will give the patients 50 mg/day of mirabegron orally for three months.	Drug: Mirabegron; Mirabegron is a beta-3 agonist approved by FDA to treat overactive bladder. Our preclinical studies showed that it is antiarrhythmic in the ventricles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint is reduction of the burden of VT detected by ICD	The patients with ICD will record the VT burden. The investigators will use that number as the primary outcomes measure.	3 months

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Ventricular fibrillation; ICD; Ventricular tachycardia; mirabegron
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Heart Arrest; Tachycardia, Ventricular; Ventricular Fibrillation; mirabegron
• Other Study ID Numbers: STUDY00004239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study is supported by the American Heart Association (AHA). The AHA does not mandate IPD for studies cited in guidelines

Drug and device information, study documents

• 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.: Yes