Ventricular Arrhythmias and Cardiac ArrestPhase 2MACH-1NCT07566208
Using Mirabegron to Control Arrhythmia-1
A Phase 2 study testing Mirabegron in people with Ventricular Arrhythmias and Cardiac Arrest, run by Cedars-Sinai Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmias and Cardiac Arrest
- What is being tested?
- Mirabegron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2026to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all the following criteria:
- Provision of signed and dated informed consent form.
- Age > 18 years old.
- Documented VT on ICD.
- with > 2 episodes of VT per month (on average) over the past 2 months.
- despite guideline-recommended medical therapy (GRMT).
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients who are pacemaker-dependent because the pacing artifacts will complicate skin sympathetic nerve activity (SKNA) analysis.
- Clinically unstable (for example, acute myocardial infarction, decompensated heart failure, undergoing cancer chemotherapy, and other acute illness requiring hospitalization)
- Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)25
- Active thyrotoxicosis
- Any experimental medication concomitantly or within 4 weeks of participation in the study
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- Currently participating in a different clinical trial
- Severe renal impairment (CrCl < 30 ml/min)
- Hepatic disease (Child-Pugh Class C)
- Pregnant
- Breastfeeding
- Cannot speak, write, and answer questions in English
- Does not have the capacity to consent
- Severe renal impairment (CrCl < 30 ml/min)
- Hepatic disease (Child-Pugh Class C)
- Pregnant
- Breastfeeding
- Cannot speak, write, and answer questions in English
- Does not have the capacity to consent
- Patients who are known to be allergic to mirabegron or skin patch electrodes
- Patients taking codeine, oxycodone, thioridazine, flecainide, propafenone, and digoxin. (see explanation below)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- Mirabegron
- Keywords
- mirabegron, Ventricular tachycardia, Ventricular fibrillation, ICD
- Medical subject headings
- Heart Arrest, Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
Mirabegron is a beta-3 agonist approved by FDA to treat overactive bladder. Our preclinical studies showed that it is antiarrhythmic in the ventricles.
| Study group | Role | What they receive |
|---|---|---|
| mirabegron | Experimental | The investigators will give the patients 50 mg/day of mirabegron orally for three months. Receives: Drug: Mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Arrhythmias and Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng-Sheng Chen, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566208
- Sponsor's protocol ID
- STUDY00004239
- Acronym
- MACH-1
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This study is supported by the American Heart Association (AHA). The AHA does not mandate IPD for studies cited in guidelines
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mirabegron to Control Arrhythmia-1
- ClinicalTrials.gov ID
- NCT07566208
- Acronym / sponsor ID
- MACH-1 / STUDY00004239
- Keywords
- mirabegron, Ventricular tachycardia, Ventricular fibrillation, ICD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mirabegron | Experimental | Drug: MirabegronThe investigators will give the patients 50 mg/day of mirabegron orally for three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, an individual must meet all the following criteria:
Key exclusion criteria (21 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirabegronMirabegron is a beta-3 agonist approved by FDA to treat overactive bladder. Our preclinical studies showed that it is antiarrhythmic in the ventricles. | Drug | mirabegron |
Primary outcome
The primary endpoint is reduction of the burden of VT detected by ICD
Time frame: 3 months
The patients with ICD will record the VT burden. The investigators will use that number as the primary outcomes measure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. This study is supported by the American Heart Association (AHA). The AHA does not mandate IPD for studies cited in guidelines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirabegron in people with Ventricular Arrhythmias and Cardiac Arrest, run by Cedars-Sinai Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng-Sheng Chen, MD (310-967-2707, peng-sheng.chen@csmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is reduction of the burden of VT detected by ICD (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.