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

2026年5月4日 更新者:Peng-Sheng Chen、Cedars-Sinai Medical Center
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.

研究概览

地位

尚未招聘

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

20

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:mirabegron
The investigators will give the patients 50 mg/day of mirabegron orally for three months.
Mirabegron is a beta-3 agonist approved by FDA to treat overactive bladder. Our preclinical studies showed that it is antiarrhythmic in the ventricles.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The primary endpoint is reduction of the burden of VT detected by ICD
大体时间:3 months
The patients with ICD will record the VT burden. The investigators will use that number as the primary outcomes measure.
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年4月29日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年5月6日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

This study is supported by the American Heart Association (AHA). The AHA does not mandate IPD for studies cited in guidelines

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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