Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 10
- 主要终点
- Average change in home systolic blood pressure at 3 months
研究概览
简要总结
The purpose of this research study is to determine whether blood pressure treatment regimens with spironolactone are better than blood pressure treatment regimens without spironolactone at lowering blood pressure in stroke survivors.
详细描述
This is a pragmatic, randomized, open-label, blinded-endpoint trial comparing spironolactone-containing antihypertensive regimens versus standard antihypertensive regimens based on the 2017 AHA/ACC guidelines in stroke survivors.
This study will randomize a total of 200 patients, 100 white and 100 non-white patients, at least three weeks after last known normal or symptom discovery/onset of their stroke to an antihypertensive regimen with spironolactone once daily or standard BP control based on the 2017 AHA/ACC guidelines for 1 year.
Participants will undergo baseline testing for neurohormonal levels and will be followed for 12 months with regular assessment of home BP readings. The primary outcome of home systolic BP will be measured at 3 months.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age ≥ 18 years
- •Symptomatic ICH confirmed by head CT or brain MRI during hospitalization OR ischemic stroke patients. Ischemic stroke will be defined by focal signs/symptoms of any duration associated with evidence of acute arterial infarction on neuroimaging or clinical evidence of cerebral focal arterial ischemic injury with symptoms persisting ≥ 24 hours.
- •Written, informed consent by patient or surrogate
- •Ability to comply with all study procedures and available for the duration of the study
排除标准
- •Secondary ICH due to trauma, vascular malformation, or tumor
- •Life expectancy < 1 year
- •Serum potassium greater than or equal to the upper limit of normal of the lab on the two most recent consecutive potassium levels prior to enrollment
- •Known hypersensitivity to spironolactone
- •Upper arm greater than 17 inches in circumference
- •Pregnancy, planned pregnancy, or breastfeeding
- •Contraindication to discontinuing mineralocorticoid antagonist therapy for 3-12 months per the investigator's discretion (e.g., refractory proteinuria)
- •Systolic BP >200 mmHg or diastolic BP >110 mmHg at the time of randomization
- •Systolic BP <120 mmHg at the time of randomization
- •Any condition which, in the judgement of the investigator, increases the risk to the patient
- •History of Addison's disease
研究组 & 干预措施
Spironolactone
Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.
干预措施: Spironolactone Pill (Drug)
Standard Care
Participants randomized to the Standard care arm will be receiving their normal routine blood pressure treatment.
结局指标
主要结局
Average change in home systolic blood pressure at 3 months
时间窗: Baseline, 3 month
The average home systolic blood pressure will be measured using a home blood pressure cuff
次要结局
- Proportion of patients achieving BP < 130/80 mm Hg(3 months)
- Number of antihypertensive medications at 3 months(3 months)
- Number of antihypertensive medications at 1 year(1 year)
- Stroke, myocardial infarction, or death(1 year)
- Change in modified Rankin Scale score(Baseline, 1 year)