Learning Implementation of Guideline-based Decision Support System for Hypertension Treatment: Testing Alternative Antihypertensive Regimens Using ACE-Inhibitors, Calcium Channel Blockers and Diuretics (LIGHT-ACD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5,000
- 试验地点
- 3
- 主要终点
- Average change in BP from first visit after the decision support system is installed to 9-month among the individuals who initiated with A, C, and D (population 1) and among those who initiated with two-drug therapy with AC, AD or CD (population 2)
研究概览
简要总结
This trial aims to compare the efficacy of several guideline-based hypertensive medication regimens initiated with Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker [A], Calcium Channel Blocker [C] and Diuretic [D].
详细描述
The LIGHT-ACD Trial is conducted based on the LIGHT trial and aims to compare the efficacy of several guideline-based hypertensive medication regimens initiated with A, C and D for BP control.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Local resident of the community/township who attend a PHC center with DSS treatment of hypertension
- •Established diagnosis of essential hypertension, with SBP≥140mmHg and <180mmHg
- •Not currently taking any antihypertensive medication or taking only one antihypertensive medication which in not B
排除标准
- •History of coronary heart disease (i.e., angina, MI, CABG, PCI, >50% stenosis of coronary artery, or positive stress test)
- •Physician-diagnosed or self-reported CKD, eGFR <60 mL/min/1.73m2 (if serum creatinine available), or currently on dialysis
- •Physician-diagnosed diabetes mellitus
- •Physician-diagnosed heart failure
- •Physician-diagnosed secondary hypertension
- •Intolerance to any class of antihypertensive medications among A, C or D
- •Other serious medical illness such as malignant cancer, hepatic dysfunction, et al.
- •Currently at the acute phase of any diseases
- •Subject is pregnant or breast feeding, or planning to become pregnant or breast feeding during study period
- •Patients measured blood pressure at home and the average self-measured home blood pressure <135/85mmHg
结局指标
主要结局
Average change in BP from first visit after the decision support system is installed to 9-month among the individuals who initiated with A, C, and D (population 1) and among those who initiated with two-drug therapy with AC, AD or CD (population 2)
时间窗: Baseline; 1 year
Average change in BP from first visit after the decision support system is installed to 9-month among population 1 (SBP 140-159 mmHg, not currently taking any antihypertensive medications) who initiated with A, C, and D and among population 2 (SBP≥160 mmHg, taking 0-1 antihypertensive medications which is not B; or SBP 140-159mmHg, taking one antihypertensive medication which is not B) who initiated with two-drug therapy with AC, AD or CD, respectively.
次要结局
- Proportion of individuals intolerant to each of the four medications.(Baseline; 1 year)
- Proportion of individuals with BP<160/100 mmHg at 9 month.(Baseline; 1 year)
- Proportion of individuals with BP<140/90 mmHg at 9 month.(Baseline; 1 year)
- Proportion of individuals who received monotherapy, two-drug treatment, three-drug treatment, or referral at 9 month.(Baseline; 1 year)
- Proportion of individuals who switched to usual care for any reason.(Baseline; 1 year)