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

改变顽固性高血压生活方式的设施和基于网络的方法

基本信息

批准号：
9068412
负责人：
James A Blumenthal
金额：
$ 5.62万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-12-01 至 2019-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9068412
关键词：
Address Adherence Adopted Adult Aerobic Affect American Antihypertensive Agents Baroreflex Behavior Behavior Therapy Biological Markers Blood Pressure Body Weight Body Weight decreased Caloric Restriction Cardiac rehabilitation Cardiovascular system Cessation of life Clinic Clinical Trials Country DASH diet Data Diastolic blood pressure Diet Habits Diet Modification Disease Diuretics Dose Education Etiology Event Exercise Exhibits Goals Health Hour Hyperlipidemia Hypertension Hypertrophy Hypotension Individual Inflammation Insulin Resistance Kidney Failure Left Ventricular Hypertrophy Life Life Style Lipids Measures Mediator of activation protein Medical Modification Motivation Myocardial Infarction Obesity Online Systems Participant Patient-Focused Outcomes Patients Pharmaceutical Preparations Pharmacological Treatment Physicians Pressoreceptors Prevalence Process Public Health Quality of life Randomized Randomized Clinical Trials Refractory Regimen Resistant Hypertension Risk Risk Factors Stroke Structure Sympathetic Nervous System Therapeutic Training Woman arterial stiffness base blood pressure reduction blood pressure regulation cardiovascular risk factor clinically significant design editorial experience fitness follow-up glycemic control healthy lifestyle high risk improved inflammatory marker insulin sensitivity/resistance intervention program lifestyle intervention men nutrition programs response sedentary standard of care therapy design unhealthy lifestyle

项目摘要

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.

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危险因素，包括中风，心肌梗塞和死亡。据估计，HTN的6800万美国成年人中有70％接受了药理治疗，但只有46％的血压（BP）得到了足够的控制。尽管同时使用3种或更多类别的降压药（包括利尿剂），但BP的患者仍然超过目标（收缩压> 140 mM Hg和/或舒张压> 90 mm Hg），但被认为具有“抗性高血压”（RH）。随着该国HTN的越来越流行，RH是一个主要的公共卫生问题，影响了750万美国人。 RH患者患CVD相关事件的风险很高，并且有必要制定有效的管理策略来帮助降低BP并降低这些人的风险。令人惊讶的是，尚无对随机临床试验（RCT）的评估，以评估结合运动，减肥和最佳营养的辅助生活方式干预是否可以帮助控制RH患者的BP并降低CVD风险。该拟议的RCT旨在评估RH患者是否可以通过在基于中心的心脏康复设施（C-LIF）（C-LIF）进行的生活方式干预措施（与标准化的教育和医生咨询控制条件（SEPA）相比，通过在基于中心的心脏康复设施（C-LIF）中提供的生活方式干预措施来降低临床意义的BP并改善CVD风险的其他生物标志物。具有RH的一百五十名男性和女性将以2：1的设计随机分配给C-Life或Sepa。我们假设C-Life参与者（1）与SEPA对照相比，（1）有氧健身性的改善，对破折号饮食的依从性更大，体重减轻更大；（2）与SEPA对照组相比，4个月后的诊所BP和门诊BP较低；（3）与SEPA对照组相比，4个月后4个月后，CVD风险生物标志物（包括动脉僵硬，胰岛素抵抗和炎症标记）的CVD风险生物标志物的改善更大；（4）与SEPA对照组相比，CVD生物标志物在1年的随访中表现出较低的诊所BP和ABP。我们还假设有氧健身性更高，对破折号饮食的依从性更好，并且减肥将与4个月和1年随访时诊所BP的降低相关。我成功，本申请中描述的生活方式干预措施可以由全国心脏康复计划采用，并为管理RH患者提供可行的非药物治疗。