NCT01541566已完成不适用
Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring
Italian Institute of Telemedicine10 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2007年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 10
- 主要终点
- Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg
研究概览
简要总结
The purpose of this study is to assess whether, in patients at high cardiovascular risk (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most effective when based on home blood pressure telemonitoring and on the feedback to the patient by the doctor between visits, or when based only on blood pressure determination during quarterly office visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated or untreated uncontrolled essential arterial hypertension (office systolic blood pressure >140 or diastolic >90 mmHg + day-time systolic blood pressure >135 or day-time diastolic blood pressure >85 mmHg)
- •Metabolic syndrome (ATP III criteria)
排除标准
- •Secondary arterial hypertension
- •Severe liver or kidney disease
- •Immunological disease
- •Cardiac arrhythmias
结局指标
主要结局
Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg
时间窗: 12 months
次要结局
- Percentage of subjects with office blood pressure <140/90 mmHg(12 months)
- Number of antihypertensive drugs(12 months)
- Number of additional medical visits(12 months)
- Level of cardiovascular risk by ESC Heart Score and Framingham(12 months)
- Target organ damage and outcomes(12 months)
- Changes in home blood pressure(12 months)
- Percentage of patients with metabolic syndrome(12 months)
- Psychological determinats of therapeutic adherence(12 months)
- Direct costs of intervention(12 months)
- Percentage of subjects with home blood pressure <135/85 mmHg(12 months)
- Changes in 24h blood pressure(12 months)
- Changes in office blood pressure(12 months)
- Adherence to treatment(12 months)
研究者
研究点 (10)
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