India Heart Study – The Ongoing Outcomes (IHS TOO)
试验速览
- 阶段
- 不适用
- 状态
- Other
- 发起方
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- The primary objective of the study is long term follow up of the natural history of the subjects enrolled for a period of 5 years.
研究概览
简要总结
High blood pressure (BP) is ranked as thethird most important risk factor for increased burden of disease in south Asia(2010). Hypertension (HTN) exerts a substantial public health burden oncardiovascular health status and healthcare systems in India. HTN is directlyresponsible for 57% of all stroke deaths and 24% of all coronary heart disease(CHD) deaths in India. Hypertension is a major cardiovascular risk with anestimated prevalence of 27% of the adult Indian population. However, bothdiagnosis and treatment of high blood pressure highly depends on method ofblood pressure measurement.
The present study proposal has an observationalprospective long-term follow up design. It aims at investigating the differencebetween standardized office and self-blood pressure measurement and relatedconsequences for diagnosis of hypertension in Indian primary care practice. Inthe long-term this study aims at providing more insight into subject’s bloodpressure profile and other subject characteristics in relation to long-termcardiovascular risk.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects aged 18 years and older without a history of hypertension
- •Office systolic blood pressure between 100 and 180 mmHg and diastolic blood pressure between 60 and 110 mmHg.
排除标准
- •Subjects who are unable or unwilling to take self-measurements of blood pressure at home
- •Subjects who do not sign informed consent
- •Office Blood pressure higher than 180 and 110 mmHg for systolic and diastolic blood pressure, respectively
- •Patients with secondary Hypertension
- •Patients already on Anti-hypertensive medication.
结局指标
主要结局
The primary objective of the study is long term follow up of the natural history of the subjects enrolled for a period of 5 years.
时间窗: 5 years
次要结局
- To have better insights on how many normotensive or white coat hypertensive patients turned hypertensive over a course of time and document their natural history.(Record any hospitalizations during follow up for HT-related problems – Time period of Diagnosis (Stroke, ACS, Renal failure etc.))