Using Mirabegron to Increase Blood Pressure in Patients With Postural Orthostatic Tachycardia Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Blood Pressure
研究概览
简要总结
This is a pilot dose-finding study to test the hypothesis that mirabegron increases systolic blood pressure (BP), prevents syncope/presyncope, and improves the quality of life (QOL), functional capacity, chest pain, and overactive bladder (OAB) symptoms in patients with postural orthostatic tachycardia syndrome (POTS) who have a documented history of hypotension inadequately responsive to conventional treatments. The American Heart Association funds this study.
详细描述
This is a pilot dose-finding study to test the hypothesis that mirabegron increases systolic blood pressure (BP), prevents syncope/presyncope, and improves the quality of life (QOL), functional capacity, chest pain, and overactive bladder (OAB) symptoms in patients with postural orthostatic tachycardia syndrome (POTS) who have a documented history of hypotension inadequately responsive to conventional treatments. The investigators will perform 24-hour ambulatory blood pressure monitoring (ABPM) and ambulatory skin sympathetic nerve activity (SKNA) recording using a Bittium Faros electrocardiogram (ECG) monitor, assess the number of syncope and presyncope episodes and determine the symptoms using validated questionnaires at baseline. The patients will then be given mirabegron (either 25 mg once daily or 50 mg once daily) for eight weeks. Afterward, the patient will return to the clinic for clinical assessments, complete questionnaires, ABPM, and ambulatory SKNA recording while still on treatment. Mirabegron will be stopped when the data collection is complete. Because mirabegron has a long half-life, the investigators will schedule a video visit with the patient 12 weeks after beginning the treatment and inquire about the patient's symptoms. The investigators will repeat all pertinent questionnaires at that time.
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
- None
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 signed and dated informed consent form.
- •Age > 18 years old.
- •Documented history of chronic (> 3 months) of orthostatic intolerance.
- •Diagnosis of syncope or pre-syncope and documented intermittent hypotension unresponsive to conventional life-style modification therapy.
- •A history of syncope (complete loss of consciousness) or presyncope (the sensation that one is about to pass out).
- •At least one documented hypotensive episode with systolic BP < 90 mmHg on 24-hr ABPM.
- •Inadequate response to conventional therapies.
排除标准
- •Patients with other potential etiologies of syncope
- •Sustained tachyarrhythmias other than sinus tachycardia. Specifically, patients with a diagnosis of atrial fibrillation, sustained (> 30 seconds) arrhythmias including paroxysmal supraventricular tachycardia, atrial flutter, ventricular tachycardia, ventricular fibrillation.
- •Symptomatic bradycardia before pacemaker implantation.
- •Heart failure with either preserved or reduced ejection fraction.
- •Wolff Parkinson-White Syndrome.
- •Stroke within the past 6 months.
- •Any history of myocardial infarction.
- •Active thyrotoxicosis.
- •Any experimental medication concomitantly or within 4 weeks of participation in the study.
- •Patients < 18 years old because mirabegron is not approved by FDA for use in children.
- •People with a history of allergy to ECG electrodes or adhesive tape.
- •Patients with known contraindications or precautions to mirabegron.
- •Hypertension
- •Severe renal impairment (calculated CrCl < 30ml/min)
- •Hepatic disease (Child-Pugh Class B)
- •Pregnant or lactation
- •Geriatric patients in long term care facilities
- •Patients who are known to be allergic to mirabegron
- •Patients taking drugs that are CYP2D6 substrates, such as midodrine. An extensive list can be found at the following website: https://drug-interactions.medicine.iu.edu/MainTable.aspx
研究组 & 干预措施
25 mg group
Ten patients will receive 25 mg mirabegron for 8 weeks.
干预措施: Mirabegron 25 MG (Drug)
50 mg group
Ten patients will receive 50 mg mirabegron for 8 weeks.
干预措施: Mirabegron 50 MG (Drug)
结局指标
主要结局
Blood Pressure
时间窗: 8 weeks
A 24-hr ambulatory blood pressure monitor (ABPM) was used to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP). The participants' average SBP is the primary outcome. We also report the average DBP in this Table. Due to technical reasons, only 7 participants in 50 mg group and 8 participants in 25 mg group had ABPM available for analysis.
次要结局
- Hypotensive episode(8 weeks)
- Overactive Bladder symptoms(8 weeks)
- Syncope(8 weeks)
- Duke Activity Status Index Questionnaire(8 weeks)
- EQ-5D-5L Questionnaire(8 weeks)
- Seattle Angina Questionnaire (SAQ)(8 weeks)
- Hypotensive Episode(8 weeks)
- Overactive Bladder Symptoms(8 weeks)
研究者
Peng-Sheng Chen
Staff Physician
Cedars-Sinai Medical Center