Beta-3 Enhanced Autonomic Therapy for POTS (BEAT-POTS)
2026年5月9日 更新者：Peng-Sheng Chen、Cedars-Sinai Medical Center
A Randomized Placebo-Controlled Clinical Trial Evaluating Mirabegron's Effectiveness in Alleviating POTS Symptoms
The study will test the hypothesis that mirabegron is more effective than a placebo in alleviating postural orthostatic tachycardia (POTS) symptoms.
研究概览
详细说明
Participants will undergo 4 weeks of randomized treatment, with an optional 4-week extension, and a final safety follow-up visit 4 weeks after discontinuation (total participation up to 12 weeks).
The investigators will perform skin sympathetic nerve activity (SKNA) recordings and assess self-reported symptom frequencies using the number of pushbutton events per day.
The patients will also record symptoms in a daily diary.
The investigators will assess quality of life (QOL) and overactive bladder (OAB) symptoms using validated questionnaires at baseline and after mirabegron treatment.
The investigators will repeat the QOL questionnaires at 4 weeks and 8 weeks in those who choose to extend therapy.
研究类型
介入性
注册 (估计的)
36
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
- 姓名：Peng-Sheng Chen, MD
- 电话号码：310-967-2707
- 邮箱：peng-sheng.chen@csmc.edu
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:
- Provision of a signed and dated informed consent form.
- Male or female, age ≥ 18 years old.
- Confirmed POTS diagnosis, which includes chronic (>3 months) orthostatic intolerance, an increase in heart rate (HR) of ≥30 beats per minute (bpm) without orthostatic hypotension (>20 mmHg drop of systolic BP) during orthostatic tests.
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 illnesses requiring hospitalization)
- Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)18
- 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)
- Prisoners
- Pregnant
- Breastfeeding
- Cannot speak, write, or answer questions in English (Validated symptom questionnaires used in this study are available only 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
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：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：mirabegron arm
25 mg
|
This is a randomized placebo controlled double blind trial comparing mirabegron with placebo in treating POTS
|
|
安慰剂比较：placebo arm
matching placebo
|
匹配安慰剂
|
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 |
|---|---|---|
|
Self-reported frequencies of cardiac-related symptoms as recorded by the number of pushbutton events per day on the monitor.
大体时间：At baseline and again immediately after the completion of drug treatment
|
Patients pushes button when there are symptoms
|
At baseline and again immediately after the completion of drug treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Malmö POTS Symptom Score
大体时间：At baseline and again immediately after the completion of drug treatment
|
It is a 12-item questionnaire in which each symptom is rated from 0 to 10 using a visual analogue scale.
The total score range is 0 (no symptom) to 120 (maximal symptom)
|
At baseline and again immediately after the completion of drug treatment
|
|
EQ-5D-5L quality of life score
大体时间：At baseline and again immediately after the completion of drug treatment
|
calculated score, best = 1, worst = -0.573
|
At baseline and again immediately after the completion of drug treatment
|
|
Duke Activity Status Index
大体时间：At baseline and again immediately after the completion of drug treatment
|
Scores range 0 to 58.2.
The higher the score, the greater the individual's functional capacity.
|
At baseline and again immediately after the completion of drug treatment
|
|
Seattle Angina Questionnaire score
大体时间：At baseline and again immediately after the completion of drug treatment
|
Measurement of Angina on a 0-100 scale.
Higher score means better status and fewer symptoms.
|
At baseline and again immediately after the completion of drug treatment
|
|
OAB-q SF
大体时间：At baseline and again immediately after the completion of drug treatment
|
Overactive bladder symptom measurements.
best = 0, worst = 100.
|
At baseline and again immediately after the completion of drug treatment
|
|
PROMIS survey
大体时间：At baseline and again immediately after the completion of drug treatment
|
PROMIS fatigue score range 30-80.
Higher score = worse fatigue.
|
At baseline and again immediately after the completion of drug treatment
|
|
skin sympathetic nerve activity (SKNA) parameters
大体时间：At baseline and again immediately after the completion of drug treatment
|
Average SKNA over 1 - minute windows, measured in μV.
The higher the number, the higher the sympathetic nerve activity.
|
At baseline and again immediately after the completion of drug treatment
|
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30日
首先提交符合 QC 标准的
2026年5月9日
首次发布 (实际的)
2026年5月13日
研究记录更新
最后更新发布 (实际的)
2026年5月13日
上次提交的符合 QC 标准的更新
2026年5月9日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY00004929
- 26BIPA1622610 (其他赠款/资助编号：The American Heart Association)
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
AHA does not require IPD for studies supported by its grants.
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
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