Biobehavioral Intervention in Heart Failure

描述(申请人提供)：心力衰竭因其高发病率、高患病率、高发病率和高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健康问题。尽管近年来在药物治疗方面取得了实质性进展，但患者的临床改善相对较小，生活质量往往仍然很差。非药物治疗受到的关注相对较少，但有可能成为药物治疗的重要辅助手段。生物反馈松弛是一种认知、生物行为、非药物干预，已被证明在有心力衰竭的病理生理和心理表现的情况下是有效的。因此，该项目的具体目标是确定生物反馈-放松训练对1)心力衰竭再住院或心脏死亡的综合主要终点、2)生活质量、3)感知控制、焦虑和抑郁的中间(中介)患者结果、以及4)手指和脚皮肤温度、心率变异性和血浆去甲肾上腺素的中间(中介)生理结果的影响。我们假设，生物反馈放松训练将减少心力衰竭再住院或心源性死亡，改善生活质量，增加知觉控制力，减少焦虑和抑郁，提高手指和脚温，改善心率变异性，并降低血浆去甲肾上腺素。为了验证这些假设，420名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)组；2)假生物反馈-放松组(安慰剂-对照组)；或3)常规护理对照组。在这些组中，患者将被分层，每组将包括50%服用血管紧张素转换酶抑制剂和50%不服用血管紧张素转换酶抑制剂。数据将在基线、3个月和12个月收集，并将使用生存分析和重复测量ANOVA进行分析。心力衰竭患者的生物反馈放松训练可能具有潜在的长期临床益处，并可能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.