Biobehavioral Intervention in Heart Failure

描述（由申请人提供）：心力衰竭因其高发病率、流行率、发病率和死亡率而被称为心血管临床医生和研究人员面临的最重要的公共卫生问题。尽管近年来在药物治疗方面取得了实质性进展，但在患者中看到的临床改善相对有限，生活质量往往仍然很差。非药物治疗受到的关注相对较少，但有可能作为药物治疗的重要辅助手段。生物反馈-放松是一种认知生物行为非药物干预，已被证明对心衰的病理生理和心理表现有效。因此，该项目的具体目的是确定生物反馈-放松训练对以下方面的影响：1)心力衰竭再住院或心脏死亡率的综合主要终点；2)生活质量；3)感知控制、焦虑和抑郁的中间（中介）患者结局；4)手指和足部皮肤温度、心率变异性和血浆去甲肾上腺素的中间（中介）生理结局。我们假设生物反馈放松训练将减少心力衰竭再住院或心脏性死亡，改善生活质量，增强感知控制，减少焦虑和抑郁，增加手指和足部温度，改善心率变异性，降低血浆去甲肾上腺素。为了验证这些假设，420例晚期心力衰竭患者将被随机分为三组：1)生物反馈放松（干预）；2)假性生物反馈松弛（安慰剂对照）；或3)常规护理控制。在这些组中，患者将分层，每组将包括50%服用和50%不服用血管紧张素转换酶抑制剂。将在基线、3个月和12个月收集数据，并使用生存分析和重复测量方差分析进行分析。心衰患者的生物反馈放松训练可能具有潜在的长期临床益处，并可作为药物治疗的重要辅助手段。

DESCRIPTION (provided by applicant): Heart failure has been called the most important public health problem facing cardiovascular clinicians and researchers because of its high and increasing incidence, prevalence, morbidity and mortality. Despite substantial advances in pharmacologic therapy made in recent years, clinical improvements seen among patients are relatively modest and quality of life often remains poor. Nonpharmacologic therapy has received relatively little attention, yet has potential to serve as an important adjunct to pharmacologic therapy. Biofeedback-relaxation, a cognitive biobehavioral nonpharmacologic intervention, has been demonstrated to be effective in conditions with pathophysiological and psychological manifestations of heart failure. Accordingly, specific aims of this project are to determine the impact of biofeedback-relaxation training on 1) the combined primary end-point of heart failure rehospitalizations or cardiac mortality, 2) quality of life; 3) intermediate (mediating) patient outcomes of perceived control, anxiety and depression, and 4) intermediate (mediating) physiologic outcomes of finger and foot skin temperature, heart rate variability and plasma norepinephrine. We hypothesize that biofeedback-relaxation training will result in decreased heart failure rehospitalizations or cardiac death, improved quality of life, increased perceived control, decreased anxiety and depression, increased finger and foot temperature, improved heart rate variability, and decreased plasma norepinephrine. To test these hypotheses, 420 patients with advanced heart failure will be randomized to one of three groups: 1) biofeedback-relaxation (intervention); 2) sham biofeedback-relaxation (placebo-control); or 3) usual care control. Within these groups, patients will be stratified such that each group will include 50% taking and 50% not taking angiotensin converting enzyme inhibitors. Data will be collected at baseline, 3, and 12 months and will be analyzed using survival analyses and repeated measure ANOVA. Biofeedback-relaxation training for patients with heart failure may have potential long-term clinical benefits and may serve as an important adjunct to pharmacologic therapy.