Treatment of anxiety in patients with coronary heart disease: Rationale and design of the UNderstanding the benefits of exercise and escitalopram in anxious patients with coroNary heart Disease (UNWIND) randomized clinical trial
Treatment of anxiety in patients with coronary heart disease: Rationale and design of the UNderstanding the benefits of exercise and escitalopram in anxious patients with coroNary heart Disease (UNWIND) randomized clinical trial
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DOI：
10.1016/j.ahj.2016.03.003
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发表时间：
2016-06-01
影响因子：
4.8
通讯作者：
Sherwood, Andrew
中科院分区：
文献类型：
--
作者：
Blumenthal, James A.;Feger, Bryan J.;Sherwood, Andrew
焦虑在冠心病（CHD）患者中非常普遍，越来越多的证据表明，高水平的焦虑与较差的预后相关。然而，很少有研究评估治疗冠心病患者焦虑对减轻症状和改善临床结果的疗效。运动和选择性5 -羟色胺再摄取抑制剂已被证明对治疗抑郁症患者有效，但尚未对患有高度焦虑的心脏病患者进行研究。UNWIND试验是一项随机临床试验，研究对象是因共病焦虑而出现不良事件风险增加的冠心病患者。150名患有冠心病和焦虑症状升高和/或诊断为焦虑症的参与者将被随机分配到12周的有氧运动（3次/周，35分钟，70%-85% VO(2)峰值），艾司西酞普兰（5- 20mg qd）或安慰剂组。在12周治疗前后，参与者将接受焦虑症状和冠心病风险生物标志物的评估，包括炎症、血脂、血红蛋白A（1c）、心率变异性和血管内皮功能的测量。主要结局包括干预后对焦虑症状和冠心病生物标志物的影响。次要结局包括临床结局（心血管住院和全因死亡）和生活质量指标。结论：UNWIND试验（临床试验）。该研究将评估有氧运动和艾司西酞普兰在改善焦虑型冠心病患者焦虑症状和降低不良临床事件风险方面的疗效。
Background Anxiety is highly prevalent among patients with coronary heart disease (CHD), and there is growing evidence that high levels of anxiety are associated with worse prognosis. However, few studies have evaluated the efficacy of treating anxiety in CHD patients for reducing symptoms and improving clinical outcomes. Exercise and selective serotonin reuptake inhibitors have been shown to be effective in treating patients with depression, but have not been studied in cardiac patients with high anxiety.Methods The UNWIND trial is a randomized clinical trial of patients with CHD who are at increased risk for adverse events because of comorbid anxiety. One hundred fifty participants with CHD and elevated anxiety symptoms and/or with a diagnosed anxiety disorder will be randomly assigned to 12 weeks of aerobic exercise (3x/wk, 35 min, 70%-85% VO(2)peak), escitalopram (5-20 mg qd), or placebo. Before and after 12 weeks of treatment, participants will undergo assessments of anxiety symptoms and CHD biomarkers of risk, including measures of inflammation, lipids, hemoglobin A(1c), heart rate variability, and vascular endothelial function. Primary outcomes include post-intervention effects on symptoms of anxiety and CHD biomarkers. Secondary outcomes include clinical outcomes (cardiovascular hospitalizations and all-cause death) and measures of quality of life.Conclusions The UNWIND trial (ClinicalTrials. gov NCT02516332) will evaluate the efficacy of aerobic exercise and escitalopram for improving anxiety symptoms and reducing risk for adverse clinical events in anxious CHD patients.