Exercise and Pharmacotherapy for Anxiety in Cardiac Patients

心脏病患者焦虑的运动和药物治疗

• 批准号: 9113594
• 负责人: James A Blumenthal
• 金额: $ 78.02万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9113594
• 关键词: Accounting; Acute Coronary Event; Adult; Adverse effects; Adverse event; Affect; American; American Heart Association; Anti-Anxiety Agents; Anxiety; Anxiety Disorders; Autonomic nervous system; Biological Markers; Blood; Blood Vessels; Cardiac; Cardiac rehabilitation; Cardiovascular system; Cause of Death; Characteristics; Cholesterol; Chronic; Clinic; Clinical; Clinical Research; Clinical Trials Design; Clinical assessments; Coronary heart disease; Data; Diagnosis; Effectiveness; Escitalopram; Event; Exercise; Health; Health Care Costs; Heart; Hospitalization; Hypertension; Inflammation; Intervention; Lexapro; Literature; Maintenance; Major Depressive Disorder; Measures; Mediating; Medical; Mental Depression; Monitor; Morbidity - disease rate; Myocardial; Odds Ratio; Outcome; Outpatients; Participant; Patients; Pharmaceutical Preparations; Pharmacotherapy; Physiological; Placebos; Population; Prevalence; Prognostic Factor; Psychosocial Factor; Quality of life; Randomized; Randomized Clinical Trials; Recommendation; Regulation; Reporting; Research; Risk; Risk Factors; Selective Serotonin Reuptake Inhibitor; Severity of illness; Smoking; Therapeutic; Time; Training; United States; Woman; Work; anxiety symptoms; anxiety treatment; anxious; base; cardiovascular risk factor; clinically significant; cost; depressive symptoms; design; exercise training; follow-up; heart disease risk; improved; improved outcome; men; mortality; outcome forecast; prognostic significance; psychologic; reduce symptoms; vascular endothelial dysfunction

 DESCRIPTION (provided by applicant): Coronary heart disease (CHD) is the leading cause of death in the United States, affecting 600,000 Americans each year. The term "cardiovascular vulnerable patient" has been used to describe patients susceptible to acute coronary events based upon plaque, blood, or myocardial characteristics. Recent evidence has suggested that anxiety, which is common in CHD patients, may be a significant and independent prognostic factor that also increases cardiovascular vulnerability. This evidence has provided a rationale for reducing anxiety in cardiac patients. Anxiolytic medications, especially selective serotonin reuptake inhibitors (SSRIs), may be effective in this regard, although the value of these medications in reducing anxiety has not been widely studied in cardiac patients and their value in improving clinical outcomes is not known. Exercise also may be effective in reducing anxiety, although the therapeutic potential of exercise has remained unfulfilled due to a paucity of data from well-designed clinical studies. The study proposed in this application will (a) evaluate the effectiveness of exercise training and anxiolytic medication in reducing anxiety in vulnerable cardiac patients; (b) examine changes in intermediate endpoints, including measures of autonomic nervous system dysregulation, vascular endothelial dysfunction, and chronic inflammation, which also serve as physiologic markers of vulnerability to adverse cardiac events; (c) follow participants for up to 4 years to assess clinical events including fatal and non fatal cardiac events, hospitalizations, and medical costs; and (d) explore possible mechanisms by which the interventions improve outcomes. One hundred fifty men and women with CHD and an anxiety disorder or elevated symptoms of anxiety will be randomly assigned to Exercise, Medication (escitalopram), or Placebo. Before and after 3 months of treatment, patients will undergo clinical assessments of anxiety and measures of autonomic nervous system regulation, vascular endothelial function, and inflammation. A six month follow-up will assess maintenance of psychological benefit and clinical outcomes will be monitored for up to 4 years. The data generated from this study will have important clinical significance by determining the extent to which exercise and medication may reduce anxiety, improve intermediate markers of CHD risk, and improve medical outcomes including clinical events and CHD-related hospitalizations.

 描述（由申请人提供）：冠心病 (CHD) 是美国的首要死因，每年影响 60 万美国人。术语“心血管脆弱患者”用于描述基于斑块、血液或心肌特征而容易发生急性冠状动脉事件的患者。最近的证据表明，在先心病患者中常见的焦虑可能是一个重要且独立的预后因素，也会增加心血管疾病的脆弱性。这一证据提供了理由 减少心脏病患者的焦虑。抗焦虑药物，尤其是选择性血清素再摄取抑制剂（SSRI）在这方面可能有效，尽管这些药物在减轻焦虑方面的价值尚未在心脏病患者中得到广泛研究，并且其在改善临床结果方面的价值尚不清楚。运动也可能有效减少焦虑，尽管由于缺乏精心设计的临床研究数据，运动的治疗潜力仍未得到发挥。本申请中提出的研究将（a）评估运动训练和抗焦虑药物在减少易受心脏病患者焦虑方面的有效性； (b) 检查中间终点的变化，包括自主神经系统失调、血管内皮功能障碍和慢性炎症的测量，这些也可作为易受不良心脏事件影响的生理标志； (c) 跟踪参与者长达 4 年以评估临床事件，包括致命和非 致命的心脏事件、住院和医疗费用； (d) 探索干预措施改善结果的可能机制。一百五十名患有先天性心脏病和焦虑症或焦虑症状加重的男性和女性将被随机分配到运动组、药物组（艾司西酞普兰）或安慰剂组。治疗前和治疗后3个月，患者将接受焦虑的临床评估以及自主神经系统调节、血管内皮功能和炎症的测量。六个月的随访将评估心理益处的维持情况，并将监测长达 4 年的临床结果。这项研究产生的数据将具有重要的临床意义，通过确定运动和药物可以在多大程度上减少焦虑，改善冠心病风险的中间标志，并改善医疗结果，包括临床事件和冠心病相关的住院治疗。