Facility and Web-based Approaches to Lifestyle Change in Resistant Hypertension

描述（由申请人提供）：高血压（HTN）被认为是不良心血管事件的最重要的危险因素，包括中风、心肌梗死和死亡。据估计，在6800万患有HTN的美国成年人中，有70%接受了药物治疗，但只有46%的人血压得到了适当的控制。尽管同时使用3种或3种以上的降压药，包括利尿剂，但血压仍高于目标（收缩压>140毫米汞柱和/或舒张压>90毫米汞柱）的患者被认为是“顽固性高血压”（RH）。随着HTN在美国的日益流行，RH已成为一个主要的公共卫生问题，影响了750多万美国人。RH患者发生心血管相关事件的风险较高，需要制定有效的管理策略来帮助这些患者降低血压和降低风险。令人惊讶的是，目前还没有随机临床试验（rct）评估以DASH饮食为特征的运动、减肥和最佳营养相结合的辅助生活方式干预是否有助于RH患者控制血压和降低心血管疾病风险。与标准化教育和医生建议对照条件（SEPA）相比，该RCT旨在评估RH患者是否可以通过中心心脏康复设施（c - liff）提供的生活方式干预实现具有临床意义的血压降低和改善CVD风险的其他生物标志物。150名RH患者将按照2:1的设计随机分配到C-LIFE或SEPA。我们假设，与SEPA对照组相比，C-LIFE参与者将(1)在4个月后表现出更大的有氧健身改善，更坚持DASH饮食，更大的体重减轻；(2)与SEPA对照组相比，4个月后临床血压和动态血压较低；(3)与SEPA对照组相比，4个月后左室肥大的消退更大，CVD风险生物标志物（包括动脉僵硬度、压力感受反射敏感性、胰岛素抵抗和炎症标志物）的改善更大；(4)与SEPA对照组相比，在1年随访中表现出较低的临床血压和ABP，并改善了CVD生物标志物。我们还假设，在4个月和1年的随访中，更好的有氧适应性、更好的DASH饮食依从性和更大的体重减轻将与更大的临床血压降低有关。如果成功，本应用中描述的生活方式干预可以被全国的心脏康复计划所采用，并为RH患者的管理提供一种可行的非药物治疗方法。

DESCRIPTION (provided by applicant): Hypertension (HTN) is considered to be the single most important risk factor for adverse cardiovascular events, including stroke, myocardial infarction and death. It has been estimated that 70% of the 68 million American adults with HTN receive pharmacological treatment, but only 46% have their blood pressure (BP) adequately controlled. Patients with BP that remains above goal (systolic blood pressure >140 mm Hg and/or diastolic blood pressure >90 mm Hg) despite the concurrent use of 3 or more classes of antihypertensive medications, including a diuretic, are considered to have "resistant hypertension" (RH). With the growing prevalence of HTN in this country, RH is a major public health concern, affecting more than 7.5 million Americans. Patients with RH are at high risk for CVD-related events, and there is a need to develop effective management strategies to help lower BP and reduce risk in these individuals. Surprisingly, there have been no randomized clinical trials (RCTs) evaluating whether an adjunctive lifestyle intervention that combines exercise, weight loss, and optimal nutrition featuring the DASH diet may help control BP and reduce CVD risk in patients with RH. This proposed RCT is designed to evaluate whether RH patients can achieve clinically significant BP lowering and improve other biomarkers of CVD risk through a lifestyle intervention delivered in a center-based cardiac rehabilitation facility (C-LIF) compared to a standardized education and physician advice control condition (SEPA). One hundred fifty men and women with RH will be randomized in a 2:1 design to C-LIFE or SEPA. We hypothesize that C-LIFE participants will (1) exhibit greater improvements in aerobic fitness, greater adherence to the DASH diet, and greater weight loss after 4 months compared to SEPA controls; (2) exhibit lower clinic BP and ambulatory BP after 4 months compared to SEPA controls; (3) exhibit greater regression of LV hypertrophy and greater improvements in CVD risk biomarkers including arterial stiffness, baroreceptor reflex sensitivity, insulin resistance, and inflammatory markers after 4 months compared to SEPA controls; (4) exhibit lower clinic BP and ABP, and improved CVD biomarkers at 1 year follow-up compared to SEPA controls. We also hypothesize that greater aerobic fitness, better adherence to the DASH diet, and greater weight loss will be associated with greater reductions in clinic BP at 4 months and at 1 year follow-up. I successful, the lifestyle intervention described in this application could be adopted by cardiac rehabilitation programs nationwide, and provide a viable non-pharmacologic treatment for managing patients with RH.