A Randomized Placebo-Controlled Clinical Trial Evaluating Mirabegron's Effectiveness in Alleviating POTS Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Self-reported frequencies of cardiac-related symptoms as recorded by the number of pushbutton events per day on the monitor.
研究概览
简要总结
The study will test the hypothesis that mirabegron is more effective than a placebo in alleviating postural orthostatic tachycardia (POTS) symptoms.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
- •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)
研究组 & 干预措施
placebo arm
matching placebo
干预措施: Placebo (Drug)
mirabegron arm
25 mg
干预措施: Mirabegron (Drug)
结局指标
主要结局
Self-reported frequencies of cardiac-related symptoms as recorded by the number of pushbutton events per day on the monitor.
时间窗: At baseline and again immediately after the completion of drug treatment
Patients pushes button when there are symptoms
次要结局
- Malmö POTS Symptom Score(At baseline and again immediately after the completion of drug treatment)
- EQ-5D-5L quality of life score(At baseline and again immediately after the completion of drug treatment)
- Duke Activity Status Index(At baseline and again immediately after the completion of drug treatment)
- Seattle Angina Questionnaire score(At baseline and again immediately after the completion of drug treatment)
- OAB-q SF(At baseline and again immediately after the completion of drug treatment)
- PROMIS survey(At baseline and again immediately after the completion of drug treatment)
- skin sympathetic nerve activity (SKNA) parameters(At baseline and again immediately after the completion of drug treatment)
研究者
Peng-Sheng Chen
Staff Physician III
Cedars-Sinai Medical Center