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

描述(由申请人提供)：高血压(HTN)被认为是包括中风、心肌梗死和死亡在内的不良心血管事件的最重要的单一危险因素。据估计，在6800万患有HTN的美国成年人中，70%接受了药物治疗，但只有46%的人的血压得到了充分的控制。尽管同时服用3种或3种以上的降压药(包括利尿剂)，但血压仍高于目标水平(收缩压140毫米汞柱和/或舒张压90毫米汞)的患者被认为患有“顽固性高血压”(RH)。随着HTN在美国的流行，RH是一个主要的公共卫生问题，影响着超过750万美国人。RH患者发生心血管相关事件的风险很高，有必要制定有效的管理策略来帮助降低这些患者的血压和风险。令人惊讶的是，还没有随机临床试验(RCT)评估结合运动、减肥和以DASH饮食为特色的最佳营养的辅助生活方式干预是否有助于控制RH患者的血压和降低心血管疾病风险。这项拟议的RCT旨在评估RH患者是否可以通过在以中心为基础的心脏康复机构(C-LIF)进行的生活方式干预与标准化的教育和医生建议控制条件(SEPA)进行比较，实现临床上显著的降压并改善心血管风险的其他生物标志物。150名患有RH的男性和女性将以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)与SEPA对照组相比，4个月后表现出更大的有氧健身改善，更多地坚持DASH饮食，以及更大的体重减轻；(2)与SEPA对照组相比，4个月后表现出更低的临床血压和动态血压；(3)与SEPA对照组相比，4个月后表现出更大的左室肥厚消退和心血管疾病风险生物标记物的改善，包括动脉僵硬、压力感受器反射敏感性、胰岛素抵抗和炎症标志物；(4)与SEPA对照组相比，1年后表现出更低的临床血压和ABP，并改善心血管疾病生物标志物。我们还假设，更好的有氧健身，更好地坚持DASH饮食，以及更大的体重减轻将与4个月后和1年随访时临床血压的更大下降相关。如果成功，本申请中描述的生活方式干预可以被全国的心脏康复项目所采用，并为RH患者的管理提供一种可行的非药物治疗。

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.