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

描述（由申请人提供）：高血压（HTN）被认为是心血管不良事件（包括卒中、心肌梗死和死亡）的最重要的单一风险因素。据估计，6800万美国HTN成年人中有70%接受药物治疗，但只有46%的血压（BP）得到充分控制。尽管同时使用3种或3种以上降压药物（包括利尿剂），但BP仍高于目标值（收缩压>140 mm Hg和/或舒张压>90 mm Hg）的患者被认为患有“顽固性高血压”（RH）。随着HTN在这个国家的日益流行，RH是一个主要的公共卫生问题，影响超过750万美国人。RH患者发生心血管疾病相关事件的风险较高，因此需要制定有效的管理策略来帮助降低血压并降低这些患者的风险。令人惊讶的是，目前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连续性生活方式干预是否有助于控制血压并降低RH患者的CVD风险。这项拟议的RCT旨在评价RH患者是否可以通过在中心心脏康复机构（C-LIF）中提供的生活方式干预与标准化教育和医生建议控制条件（SEPA）相比，实现具有临床意义的BP降低并改善CVD风险的其他生物标志物。150例RH男性和女性患者将以2：1的比例随机分配至C-LIFE或SEPA组。我们假设，C-LIFE参与者将（1）与SEPA对照组相比，在4个月后表现出更大的有氧健身改善，更大的DASH饮食依从性和更大的体重减轻;（2）与SEPA对照组相比，在4个月后表现出更低的门诊血压和动态血压;（3）表现出LV肥大的更大消退和CVD风险生物标志物的更大改善，包括动脉僵硬度、压力感受器反射敏感性，与SEPA对照相比，4个月后显示出较低的临床BP和ABP，以及改善的CVD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个月和1年随访时门诊血压的更大降低相关。如果成功，本申请中描述的生活方式干预可以被全国范围内的心脏康复计划采用，并为管理RH患者提供可行的非药物治疗。

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.