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

• 批准号: 8818651
• 负责人: James A Blumenthal
• 金额: $ 80.13万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-12-01 至 2019-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8818651
• 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; 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; public health relevance; response; sedentary; standard of care; therapy design; unhealthy lifestyle

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（包括中风、心肌梗死和死亡）的最重要的单一危险因素。据估计，6800 万患有高血压的美国成年人中有 70% 接受了药物治疗，但只有 46% 的血压 (BP) 得到了充分控制。尽管同时使用 3 类或更多类抗高血压药物（包括利尿剂），但血压仍高于目标（收缩压 >140 mm Hg 和/或舒张压 >90 mm Hg）的患者被认为患有“难治性高血压” “（RH）。随着美国高血压患病率的不断上升，RH 已成为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 CVD 相关事件的风险很高，需要制定有效的管理策略来帮助降低血压并降低这些个体的风险。令人惊讶的是，目前尚无随机临床试验 (RCT) 评估以 DASH 饮食为特色的结合运动、减肥和最佳营养的辅助生活方式干预是否有助于控制 RH 患者的血压并降低 CVD 风险。这项拟议的随机对照试验旨在评估 RH 患者是否可以通过在中心心脏康复设施 (C-LIF) 中提供的生活方式干预，与标准化教育和医生建议对照相比，实现临床显着的血压降低并改善 CVD 风险的其他生物标志物条件 (SEPA)。一百五十名患有 RH 的男性和女性将以 2:1 的设计随机分配至 C-LIFE 或 SEPA。我们假设 C-LIFE 参与者 (1) 与 SEPA 对照组相比，4 个月后在有氧健身方面表现出更大的改善，对 DASH 饮食的坚持程度更高，并且体重减轻幅度更大； (2) 4 个月后，与 SEPA 对照相比，临床血压和动态血压较低； (3) 与 SEPA 对照相比，4 个月后左室肥厚的消退更大，CVD 风险生物标志物的改善更大，包括动脉僵硬度、压力感受器反射敏感性、胰岛素抵抗和炎症标志物； (4) 与 SEPA 对照相比，在 1 年随访中表现出较低的临床血压和 ABP，以及改善的 CVD 生物标志物。我们还假设，更强的有氧运动、更好地坚持 DASH 饮食以及更大的体重减轻将与 4 个月和 1 年随访时临床血压的更大降低相关。我成功了，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项目采用，并为管理 RH 患者提供可行的非药物治疗。