Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV (Post 4)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 134
- 试验地点
- 17
- 主要终点
- The primary outcome measure will be the proportion of patients having at least one syncope recurrence.
研究概览
简要总结
About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving and have reduced quality of life. There are no therapies that have withstood the test of adequately designed and conducted randomized clinical trials. Midodrine is a prodrug whose metabolite is an alpha-1 adrenergic agonist that increases venous return to the heart and raises blood pressure. There is considerable lower level evidence that it might prevent vasovagal syncope.
The investigators will test the hypothesis that Midodrine prevents recurrences of syncope in patients with moderate to severe vasovagal syncope.
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
- •Patients will be eligible if they have:
- •≥2 syncopal spells in the year preceding enrolment, and
- •≥ -2 points on the Syncope Symptom Score for Structurally Normal hearts, and
- •Age ≥ 18 years with informed consent.
排除标准
- •Patients will be excluded if they have:
- •other causes of syncope, such as ventricular tachycardia, complete heart block, postural hypotension or hypersensitive carotid sinus syndrome,
- •an inability to give informed consent,
- •important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia,
- •hypertrophic cardiomyopathy,
- •a permanent pacemaker,
- •a seizure disorder,
- •urinary retention,
- •hypertension defined as >140/90 mm Hg,
- •hepatic disease,
- •glaucoma or
- •a 5-minute stand test resulting in diagnoses of Postural Orthostatic Tachycardia Syndrome or Orthostatic Hypotension.
研究组 & 干预措施
midodrine hydrochloride pills
干预措施: midodrine hydrochloride (Drug)
oral placebo or sugar pill
干预措施: midodrine hydrochloride (Drug)
oral placebo or sugar pill
干预措施: matching placebo (Drug)
结局指标
主要结局
The primary outcome measure will be the proportion of patients having at least one syncope recurrence.
时间窗: 1 year.
次要结局
- A secondary outcome will be the time between the first and second syncope recurrences.(1 year)
- A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)).(1 year.)
- A secondary outcome will be the frequency of syncopal spells.(1 year)
- A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL.(1 year)
研究者
Dr. Bob Sheldon
Professor of Cardiac Sciences, Medicine and Medical Genetics
University of Calgary