Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study

描述（由申请人提供）： 控制血压治疗难治性高血压：一项初步研究。背景：难治性高血压（TRH），即，血压（BP）高于目标>3 BP药物影响数百万人，并导致健康差距。在临床试验中，患者的依从性得到证实，BP药物被系统地滴定以达到控制，约20%的患者患有TRH，这表明目前的治疗策略对TRH的有效性有限。这项试点研究探讨了四种循证方法的可行性，安全性和初步有效性，以改善TRH的BP控制。这四种策略包括在合格患者中添加醛固酮拮抗剂（AAEP），肾素治疗指导治疗（RTGT），临床高血压专科护理（CHSC）和RTGT+CHSC。假设：明确病理生理机制（RTGT）和/或专家咨询（CHSC）将比“盲目”增加合格患者的醛固酮拮抗剂（AAEP）更能改善血压控制。具体目标：在不同患者组和临床环境中评估四种循证治疗策略治疗难治性高血压（TRH）的可行性、安全性和初步比较有效性，以检验RTGT和/或CHSC比AAEP更有效控制TRH血压的假设。假设：通过收集患者、医疗服务提供者和工作人员在干预后的经验和见解，将确定实施AAEP、RTGY和CHSC的障碍和促进因素，从而为示范研究的设计提供信息。具体目标。进行干预后患者问卷调查和访谈，工作人员和提供者焦点小组和在线SWOT，以确定AAEP，RTGY和CHSC的障碍和促进因素，这将为真实的世界实践环境中的示范研究提供信息。研究方法：为不同患者人群提供护理的8个不同诊所（>1个社区卫生中心、单点和多点初级保健诊所、社区住院医师培训计划）将随机分配至4个研究组之一。每个中心将入组18名TRH患者（36/组）。所有诊所都接受BpTRU监测仪和培训，以标准化血压测量并“消除”白色被毛高血压。关键研究数据包括患者人口统计学、访视、BP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）分析与供应商和工作人员和患者的问卷调查和访谈将用于评估研究的几个方面，并指导示范研究设计。重要性：TRH是常见的医疗条件，相对无效的治疗方案是一个重要的影响因素。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，减少临床并发症和相关的健康差异。(End摘要）

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)