Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study

描述(由申请人提供)： 难治性高血压患者的血压控制：一项初步研究。背景：难治性高血压(TRH)，即服用3BP药物后血压超过目标水平，影响着数百万人，并造成健康差距。在临床试验中，确认患者的依从性，并系统地滴定BP药物以达到控制，约20%的患者患有TRH，这表明当前治疗策略的有限有效性导致了TRH。这项先导性研究检验了四种循证方法改善TRH中BP控制的可行性、安全性和初步有效性。这四种策略包括在符合条件的患者中增加一种醛固酮拮抗剂(AAEP)、肾素治疗指导疗法(RTGT)、临床高血压专科护理(CHSC)和RTGT+CHSC。假设：确定病理生理机制(RTGT)和/或专家会诊(CHSC)将比在符合条件的患者中盲目添加醛固酮拮抗剂(AAEP)更能改善血压控制。具体目的：评估四种循证治疗难治性高血压(TRH)策略在不同患者组和临床环境中的可行性、安全性和初步比较有效性，以验证RTGT和/或CHSC在TRH中控制血压比AAEP更有效的假设。假设：在干预后引出患者、提供者和工作人员的经验和见解将确定实施AAEP、RTGY和CHSC的障碍和促进者，这将为实证研究的设计提供信息。明确目标。进行干预后患者问卷和访谈、员工和提供者焦点小组以及在线SWOT，以确定AAEP、RTGY和CHSC的障碍和促进者，从而为现实世界实践环境中的实证研究提供信息。方法：为不同患者群体提供护理的8个不同的诊所(1个社区卫生中心、单个和多个地点的初级保健诊所、社区住院医师培训计划)将被随机分配到4个研究组中的1个。每个Cilnic将招募18名TRH患者(36例/ARM)。所有诊所都接受了BpTRU监测仪和培训，以标准化血压测量并‘消除’白大衣高血压。关键研究数据包括患者人口统计数据、就诊次数、血压值、药物和实验室数据。研究后焦点小组和优势、劣势、机会、威胁(SWOT)分析与提供者和员工以及患者问卷和访谈将用于评估研究的多个维度，并指导实证研究设计。意义：TRH是常见的疾病，相对无效的治疗方案是一个重要的因素。长期目标是建立实用、有效和可广泛复制的方法来控制TRH中的BP，并减少临床并发症和相关的健康差异。(摘要结束)

DESCRIPTION (provided by applicant): Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study. Background: Treatment resistant hypertension (TRH), i.e., blood pressure (BP) above goal on >3 BP medications affects millions of people and contributes to health disparities. In clinical trials, where patient compliance is confirmed and BP meds are systematically titrated to attain control, ~20% of patients have TRH, which suggests limited effectiveness of current treatment strategies contributes to TRH. This pilot study examines the feasibility, safety, and preliminary effectiveness of four evidence-based approaches to improving BP control in TRH. The four strategies include adding an aldosterone antagonist in eligible patients (AAEP), renin treatment-guided therapeutics (RTGT), clinical hypertension specialist care (CHSC), and RTGT+CHSC. Hypothesis: Defining pathophysiological mechanisms (RTGT) and/or expert consultation (CHSC) will improve BP control more than 'blindly' adding an aldosterone antagonist in eligible patients (AAEP). Specific aim: Assess the feasibility, safety, and preliminary comparative effectiveness in a diverse group of patients and clinical settings of four evidence-based treatment strategies for treatment resistant hypertension (TRH) to test the hypothesis that RTGT and/or CHSC are more effective than AAEP for controlling BP in TRH. Hypothesis: Eliciting patient, provider and staff experiences and insights post intervention will identify barriers and facilitators to implementing AAEP, RTGY, and CHSC that will inform design of the demonstration study. Specific Aim. Conduct post-intervention patient questionnaires and interviews and staff and provider focus groups and an online SWOT to identify barriers and facilitators to AAEP, RTGY and CHSC that will inform the demonstration study in real world practice settings. Methods: 8 diverse clinics (>1 community health centers, single & multi-site primary care clinics, community residency training programs) that provide care for a diverse patient population will be randomized to 1 of 4 study arms. Each cilnic will enroll 18 TRH patients (36/arm). All clinics receive BpTRU monitors and training to standardize BP measurements and 'eliminate' white coat hypertension. Key study data include patient demographics, visits, BP values, meds, and lab data. Post study focus groups and strengths, weaknesses, opportunities, threats (SWOT) analysis with providers and staff and patient questionnaire and interviews will be used to evaluate several dimensions of the study and guide the demonstration study design. Significance: TRH is common medical condition, and relatively ineffective treatment regimens are a significant contributing factor. The long-term goal is to establish practical, effective, and widely replicable approaches for controlling BP in TRH and reducing clinical complications and related health disparities. (End of Abstract)