A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension (ATRAX Trial)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 136
- 主要终点
- difference in the rate of paroxysmal hypertension symptoms cessation between sertraline and placebo groups
研究概览
简要总结
There is currently no established treatment for paroxysmal hypertension, but selective serotonin reuptake inhibitors showed good effect in previous reports. This double-blind, placebo controlled, prospective multicenter clinical trial will assess the efficacy of sertraline on cessation or reduction of symptoms of paroxysmal arterial hypertension. 136 patients with documented hypertensive paroxysms with abrupt elevations of blood pressure and distressful physical symptoms will be randomized in a 1:1 ratio to receive sertraline, 50 mg daily, or matching placebo as an add-on to their chronic medication. Effect of the treatment on patient symptoms, office and ambulatory blood pressure and side effects will be evaluated after 3 months. If proven effective, sertraline might become a standard treatment for this condition.
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
- •Study will enroll adult patients (age >18 years) with hypertensive paroxysms during the past 6 months (preferably during the past 6 weeks) - abrupt elevations of systolic blood pressure (BP) ≥20% compared to previous measured systolic BP value before paroxysm, or ≥20% compared to mean systolic BP on 24-hour ambulatory blood pressure monitoring (ABPM), or ≥20% compared to measured office systolic BP, documented by a clinician or home blood pressure monitor, requiring physician or emergency room visit or the use of any rescue antihypertensive medication. Hypertensive paroxysms may be accompanied by abrupt onset of one or more distressful physical symptoms, such as headache, chest pain, dizziness, nausea, palpitations, flushing, and diaphoresis.
排除标准
- •Pregnancy or breastfeeding, hypersensitivity to sertraline (Zoloft®) or of the the components of this drug. Current use of sertraline or any other selective serotonin reuptake inhibitor (SSRI), mono-amin oxidase (MAO) inhibitors, selegiline, moclobemide, linezolide, pimozide. Current use of other serotoninergic drugs (eg. tryptofane, triptane and other 5-HT agonists), tramadol or dopamine antagonists (including antipsychotics).
研究组 & 干预措施
Sertraline
sertraline, 25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial
干预措施: Sertraline (Drug)
Placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
difference in the rate of paroxysmal hypertension symptoms cessation between sertraline and placebo groups
时间窗: 3 months of treatment
difference in the rate of paroxysmal hypertension symptoms reduction between sertraline and placebo groups
时间窗: 3 months
次要结局
- side effects of the treatment(3 months)
- difference in the fall of mean office and ambulatory systolic and diastolic blood pressure between groups(3 months)
研究者
Jan Vaclavík
Jan Václavík, MD. Ph.D. Assoc. Prof.
Palacky University