Replication of the TRANSCEND Antihypertensive Trial in Healthcare Claims Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40,048
- 试验地点
- 1
- 主要终点
- Relative hazard of composite outcome of Congestive Heart Failure, Stroke, MI, and Mortality
研究概览
简要总结
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
详细描述
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals 55 years of age with 1 of the following:
- •Coronary artery disease
- •1a. Previous myocardial infraction ( > 2 days post uncomplicated MI)
- •1b. Stable angina or unstable angina > 30 days before informed consent and with documented evidence of multivessel coronary artery disease
- •1c. Multi-vessel PTCA >30 days before informed consent
- •1d. Multi-vessel CABG surgery > 4 years before informed consent, or with recurrent angina following surgery
- •Peripheral artery disease
- •2a. Previous limb bypass surgery or Previous limb bypass surgery or angioplasty
- •2b. Previous limb or foot amputation
- •2c. Intermittent claudication, with ankle:arm BP ratio =< 0.80 on at least 1 side
- •2d. Significant peripheral artery stenosis ( > 50%) documented by angiography or non-invasive testing
- •Cerebrovascular disease
- •3a. Previous stroke
- •3b. Transient ischemic attacks >7 days and <1 year before informed consent
- •Diabetus mellitus
- •4a. Diabetes mellitus High-risk diabetics with evidence of endorgan damage
排除标准
- •Medication use
- •1a. Inability to discontinue ACE inhibitors or ARB
- •1b. Known hypersensitivity or intolerance to ACE inhibitors or ARB (patient intolerant of ACE inhibitor can be enrolled in TRANSCEND)
- •Cardiovascular disease (HF)
- •2a. Symptomatic congestive heart failure
- •2b. Hemodynamically significant primary valvular or outflow tract obstruction
- •2c. Constrictive pericarditis
- •2d. Complex congenital heart disease
- •2e. Syncopal episodes of unknown etiology <3 months before informed consent
- •2f. Planned cardiac surgery or PTCA <3 months of informed consent
- •2g. Uncontrolled hypertension on treatment (eg, BP >160/100 mm Hg)
- •2f. Heart transplant recipient
- •2g. Stroke due to subarachnoid hemorrhage
- •Other conditions
- •3a. Significant renal artery disease
- •3b. Hepatic dysfunction
- •3c. Uncorrected volume or sodium depletion
- •3d. Primary hyperaldosteronism
- •3e. Hereditary fructose intolerance
- •3f. Other major noncardiac illness expected to reduce life expectancy or interfere with study participation
- •3g. Simultaneously taking another experimental drug
- •3h. Significant disability precluding regular follow-up visits
- •3I. Unable or unwilling to provide written informed consent
研究组 & 干预措施
Loop diuretics, thiazides, dihydropyridines
Reference group
干预措施: Loop diuretics, thiazides, dihydropyridines (Drug)
Telmisartan
Exposure group
干预措施: Telmisartan (Drug)
结局指标
主要结局
Relative hazard of composite outcome of Congestive Heart Failure, Stroke, MI, and Mortality
时间窗: Through study completion (a median of ***118-123**** days)
Relative hazard of composite outcome of Congestive Heart Failure, Stroke, MI, and Mortality - Please refer to uploaded protocol for full definition due to size limitations.
次要结局
未报告次要终点
研究者
Shirley Vichy Wang
Associate Professor of Medicine
Brigham and Women's Hospital