Treatment of Hypertension In Adults with ThiaZIDES: Pragmatic Trial Pilot Study

使用噻嗪类药物治疗成人高血压：务实试验试点研究

• 批准号: 9115218
• 负责人: KAREN L MARGOLIS
• 金额: $ 32.7万
• 依托单位: HEALTHPARTNERS INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9115218
• 关键词: Adult; Advanced Development; Adverse effects; Antihypertensive Agents; Behavior; Blood Pressure; Cardiovascular system; Caring; Cessation of life; Chlorthalidone; Clinical; Clinical Treatment; Clinical Trials; Cluster randomized trial; Data; Data Collection; Databases; Diuretics; Dose; Drug Combinations; Effectiveness; Electrolytes; Electronic Health Record; Event; Feasibility Studies; Guidelines; Health; Health system; Healthcare; Heart failure; Hospitalization; Hydrochlorothiazide; Hypertension; Hypotension; Intervention; Intervention Studies; Measures; Methods; Modeling; Monitor; Myocardial Infarction; Nature; Outcome; Outcome Study; Participant; Patients; Pharmaceutical Preparations; Pharmacy facility; Physicians; Pilot Projects; Placebos; Pragmatic clinical trial; Primary Care Physician; Randomized; Randomized Controlled Trials; Recommendation; Regimen; Renal function; Research Design; Research Infrastructure; Safety; Sample Size; Secure; Site; Solid; Specific qualifier value; Stroke; Study Subject; Testing; Thiazide Diuretics; Time; Validation; Work; active comparator; base; blood pressure reduction; clinical practice; compare effectiveness; cost; design; evidence base; experience; follow-up; group intervention; health information technology; hypertension treatment; medication compliance; mortality; novel strategies; open label; pragmatic trial; prevent; randomized trial; standard of care; study population; success; thiazide; treatment as usual; trial comparing

 DESCRIPTION (provided by applicant): For several decades, U.S. hypertension treatment guidelines have recommended a low-dose diuretic such as hydrochlorothiazide (HCTZ) or chlorthalidone (CTD) as initial monotherapy in a stepped-care approach or as part of an initial two-drug combination. In numerous large clinical trials, CTD-based regimens have significantly reduced rates of cardiovascular events such as stroke, heart failure, and cardiovascular mortality compared with placebo, usual care, or active comparators. In contrast, few outcome studies have compared HCTZ-based regimens with other treatments, and they have generally found HCTZ to be less effective than non-thiazide comparators in preventing cardiovascular events. The two drugs have never been compared directly in a large trial. Despite the empirical evidence favoring CTD, HCTZ is much more widely used in clinical practice. The proposed R34 is a pilot study conducted in two large integrated health systems to test methods and feasibility for an eventual pragmatic randomized trial comparing the effectiveness of HCTZ and CTD for preventing cardiovascular events and mortality. Using a cluster-randomized design, we will allocate 40 primary care physicians and their adult hypertensive patients who currently use HCTZ (N=2,000) to either convert HCTZ users to CTD (intervention group) or to continue HCTZ (usual care group). The pilot study and planned full- scale trial will use existing health care infrastructure and electronic health records to identify eligible study subjects, distribute study medication, and collect operational and outcomes data. For this pilot study, Aim 1 will document that the intervention is delivered as intended. Aim 2 will compare safety in intervention and usual care patients. Aim 3 will refine the pilot study design and identify critical factors for intervention success using a mixed-methods approach. Aim 4 will refine estimates of sample size. Finally, Aim 5 will determine the costs of ascertaining outcomes and estimate per-participant costs for the full-scale trial. The pilot study will produce data that are necessary an sufficient to inform the planning of a full-scale trial comparing CTD and HCTZ and will advance the development of methods for pragmatic trials.

 描述（由适用提供）：几十年来，美国高血压治疗指南建议使用低剂量利尿剂，例如氢氯噻嗪（HCTZ）或氯噻酮（CTD）作为初始单单疗法，或作为阶梯式护理方法或作为最初两次药号组合的一部分。在许多大型临床试验中，与安慰剂，通常的护理或主动比较剂相比，基于CTD的方案的心血管事件发生率显着降低，例如中风，心力衰竭和心血管死亡率。相比之下，很少有结果研究比较了基于HCTZ的方案与其他治疗方法，并且通常发现HCTZ在预防心血管事件方面的效率低于非噻嗪类比较器。这两种药物从未在大型试验中直接进行比较。尽管有有利于CTD的经验证据，但HCTZ在临床实践中被广泛使用。拟议的R34是一项在两个大型综合卫生系统中进行的试验研究，用于测试方法，可行性最终的务实随机试验比较了HCTZ和CTD对防止心血管事件和死亡率的有效性。我们将使用集群随机设计，分配40名初级保健医生及其成年高血压患者，他们目前使用HCTZ（n = 2,000）将HCTZ用户转换为CTD（干预组）或继续HCTZ（通常的护理小组）。试点研究和计划的全尺度试验将使用现有的医疗保健基础设施和电子健康记录来确定合格的研究对象，分发研究药物并收集运营和结果数据。对于这项试点研究，AIM 1将记录干预措施按预期进行。 AIM 2将比较干预和通常的护理患者的安全性。 AIM 3将完善试点研究设计，并使用混合方法方法确定干预成功的关键因素。 AIM 4将完善样本量的估计值。最后，AIM 5将确定确定结果的成本，并估算全面试验的每一次参与者成本。试点研究将产生足以为比较CTD和HCTZ进行全面试验的规划提供必要的数据，并将推动开发实用试验的方法。