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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mirabegron | Experimental | The investigators will give the patients 50 mg/day of mirabegron orally for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron | Drug | Mirabegron is a beta-3 agonist approved by FDA to treat overactive bladder. Our preclinical studies showed that it is antiarrhythmic in the ventricles. |
|
| 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 |
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Inclusion Criteria:
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.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng-Sheng Chen, MD | Contact | 310-967-2707 | peng-sheng.chen@csmc.edu |
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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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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |