NCT04607239Unknown不适用
HOme telemonitoRing of Arterial hypertensiOn With antihypertenSive Treatment Titration: a Randomized COntrolled prosPEctive Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Mean of 24h systolic blood pressure (SBP)
研究概览
简要总结
Rater blinded, multi-center, prospective, randomized controlled study comparing mean 24 hour systolic blood pressure of eligible hypertensive patients in the TELEMONITORIN group versus the USUAL CARE group, at 6 months after inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included are patients with:
- •age ≥ 35 years old
- •newly diagnosed hypertention
- •uncontrolled hypertention
排除标准
- •Excluded are patients with:
- •orthostatic hypotension
- •chronic renal failure (serum creatinine > 200 micromol / L)
- •acute coronary syndrome
- •coronary revascularization or stroke within the past 3 months
- •known secondary causes of hypertension
- •pregnancy
- •New York Heart Association Class III or IV heart failure or left ventricular ejection fraction < 30%
- •dementia or another cause that prevents the application of remote monitoring
结局指标
主要结局
Mean of 24h systolic blood pressure (SBP)
时间窗: 0 - 180 days
The change from baseline of mean 24-hour systolic blood pressure (SBP) at 6 months of follow-up
次要结局
- percentage of Dipping(0-180 days)
- frequency of cardiovascular complications(180 days)
- Mean of the Short Form survey (SF-12) scores(0-180 days)
- Mean of 24h diastolic blood pressure (DBP)(0-180 days)
- percentage of blood pressure load(0-180 days)
研究者
研究点 (1)
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