Using Mirabegron to Control Arrhythmia-1 (MACH-1)
研究概览
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
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名:Peng-Sheng Chen, MD
- 电话号码:310-967-2707
- 邮箱:peng-sheng.chen@csmc.edu
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
- with > 2 episodes of VT per month (on average) over the past 2 months.
- 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:
- 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
- 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)
学习计划
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
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- STUDY00004239
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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