CTRI/2020/07/026524招募中不适用
Prospective observational study to determine aetiologies, presentation, clinical practice patterns and outcomes of hypertension in high risk hypertensive patients in India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- 1.Proportion of patients achieving their BP goals as per latest hypertension guidelines (ESC/ESH 2018 and IGH 2019 guidelines) at 12 months
研究概览
简要总结
Prospective observational study to determine aetiologies, presentation, clinical practice patterns and outcomes of hypertension in high risk hypertensive patients in India.
Despite the high prevalence of HTN in India, the awareness, treatment and control status are low in Indian in urban as well as rural populations. This could be attributed to a variety of socioeconomic factors - low educational status, poverty, rural residence, as well as physiological factors like obesity. This study aims to collect real-world data from Indian population about the blood pressure control with the antihypertensive drugs used in high-risk hypertensives.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient willing to give informed consent.
- •2.Patients both males and females 18 years or older with essential hypertension (As per ESC/ESH 2018 and IGH 2019 guidelines) for at least 4 weeks, following up in public and private centres and after signing a consent form.
- •3.Patients defined as high-risk and very high-risk hypertensive as per ESC/ESH 2018 [17] and IGH 2019 guidelines [11] as per the check-list below: a.Grade 3 hypertension (SBP ≥180 mm Hg OR DBP ≥110 mm Hg) with any one of the following: i.No risk, 1-2 risk factor or ≥3 cardiovascular risk factors ii.Asymptomatic HMOD (hypertension-mediated organ damage) iii.CKD grade 3 (eGFR >30 to 59 ml/min/1.73m2), or grade 4 (eGFR <30 ml/min/1.73m2) iv.Diabetes mellitus without/with organ damage v.Established CVD b.Grade 2 hypertension (SBP 160-179 mm Hg OR DBP 100-109 mm Hg) with any one of the following: i.Uncomplicated hypertension with ≥3 cardiovascular risk factors ii.Asymptomatic HMOD (hypertension-mediated organ damage) iii.CKD grade 3 (eGFR >30 to 59 ml/min/1.73m2), or grade 4 (eGFR <30 ml/min/1.73m2) iv.Diabetes mellitus without/with organ damage v.Established CVD c.Grade 1 hypertension (SBP 140-159 mm Hg OR DBP 90-99 mm Hg) with any one of the following: i.Asymptomatic HMOD (hypertension-mediated organ damage) ii.CKD grade 3 (eGFR >30 to 59 ml/min/1.73m2), or grade 4 (eGFR <30 ml/min/1.73m2) iii.Diabetes mellitus without/with organ damage iv.Established CVD.
排除标准
- •1.Patients with secondary hypertension (secondary hypertension is the hypertension caused by an identifiable underlying primary cause).
- •2.Pregnant and lactating women.
- •3.Patient refusing consent for enrolment.
- •4.Any patient as per the discretion of the physician.
结局指标
主要结局
1.Proportion of patients achieving their BP goals as per latest hypertension guidelines (ESC/ESH 2018 and IGH 2019 guidelines) at 12 months
时间窗: 12 months
次要结局
- 1.Proportion of patients with macrovascular clinical outcomes – [All-cause mortality, MI, stroke, Coronary artery disease, heart failure [HF], and peripheral arterial disease)] at 12 months(12 months)
- 2.Proportion of patients with microvascular clinical outcomes – [retinopathy, nephropathy and neuropathy] at 12 months(12 months)
- 3.Proportion of high-risk hypertensive patients with both modifiable and non-modifiable risk factors at baseline(Baseline)
- Proportion of patients with Co-morbidities at baseline (DM, Dyslipidaemias, CKD, CVD, Heart Failure, Stroke/TIA, MI, Neuropathy, Retinopathy and/or Other)(Baseline)
- 5.Clinical practice patterns (diagnosis [parameters considered to make diagnosis; routine diagnostic measures], treatment and drug utilization patterns, investigations [investigations performed to evaluate the patients]) and relationship to clinical outcomes(Baseline)
研究者
研究点 (2)
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