Nutrition Intervention to Reduce Symptoms in Patients with Advanced Heart Failure

描述（由申请人提供）：对于大多数晚期心力衰竭患者，药物治疗仅部分有效缓解心力衰竭症状。因此有 建议在诊断后立即开始姑息治疗。有必要补充，非药物干预，可以很容易地由卫生保健提供者提供姑息治疗。已经确定了心力衰竭症状的三个主要病理途径：液体超负荷、炎症和氧化应激。先前的研究已经证明，三种营养素钠、ω-3脂肪酸和番茄红素可以改变这些病理途径。到目前为止，临床试验只单独测试了每种营养素。有强有力的理论依据表明，针对所有三种营养素的联合干预将在缓解晚期心力衰竭症状方面具有实质性益处。因此，本研究的目的是测试6个月的营养干预或饮食钠减少联合补充番茄红素和ω-3脂肪酸对心力衰竭症状、健康相关生活质量以及心力衰竭再住院或全因死亡时间的影响。这项双盲安慰剂对照研究的目的是：1）确定6个月营养干预对症状负担的影响3个月和6个月时（水肿、气短和疲劳）和健康相关生活质量，以及自基线起12个月内至心力衰竭再住院或全因死亡的时间; 2）比较营养干预组和安慰剂组在3个月和6个月时的膳食钠摄入量、炎症和氧化应激标志物;以及3）比较营养干预组和安慰剂组在3个月和6个月时的体重、血清番茄红素和红细胞ω-3指数。共有175名晚期心力衰竭患者将被随机分配到营养干预组或安慰剂组（每组75名）。营养干预组将接受基于理论的教育和技能建设干预，旨在将膳食钠摄入量降至每天约2 g。研究护士将在6个月内进行4次家访和1次随访电话，以提供教育技能建设干预。干预组将服用3粒omega-3脂肪酸胶囊（350毫克二十碳六烯酸和50毫克二十二碳六烯酸），并每天食用番茄汁或其他含有20-25毫克番茄红素的番茄制品，持续6个月。安慰剂组将接受相同次数的访视和电话访视，但仅提供一般营养信息。他们将服用3粒含有大豆油的安慰剂胶囊（500 mg/胶囊），并在6个月内每天食用他们选择的不含番茄红素的果汁。将由对分组设盲的研究助理在基线、3个月和6个月时亲自收集数据。将通过电话对患者进行额外6个月的随访，以收集9个月和12个月时症状负担和生活质量以及心力衰竭住院和全因死亡率的长期数据。

DESCRIPTION (provided by applicant): For a majority of patients with advanced heart failure, medical treatment is only partially effective in relieving heart failure symptoms. Therefore, it is recommended that palliative care be initiated soon after diagnosis. There is a need for complementary, nonpharmacologic interventions that could be easily implemented by health care providers to provide palliative care. Three major pathologic pathways underlying heart failure symptoms have been identified: fluid overload, inflammation, and oxidative stress. Prior research has demonstrated that three nutrients-sodium, omega-3 fatty acids, and lycopene-can alter these pathologic pathways. Clinical trials to date have only tested each nutrient individually. There is strong theoretical rationale that a combined intervention targeting all thre nutrients would have substantial benefit in relieving symptoms in advanced heart failure. Therefore, the purposes of this study are to test the effects of a 6-month nutrition intervention o dietary sodium reduction combined with supplementation of lycopene and omega-3 fatty acids on heart failure symptoms, health-related quality of life, and time to heart failure rehospitalization or all-cause death. The aims of this double blind-placebo controlled study are 1) to determine the effects of a 6-month nutrition intervention on symptom burden (edema, shortness of air, and fatigue) and health related quality of life at 3 and 6 months, and time to heart failure rehospitalization or all-cause death over 12 months from baseline; 2) compare dietary sodium intake, inflammation, and markers of oxidative stress between the nutrition intervention group and a placebo group at 3 and 6 months; and 3) compare body weight, serum lycopene, and erythrocyte omega-3 index between the nutrition intervention group and a placebo group at 3 and 6 months. A total of 175 patients with advanced heart failure will be randomized to either the nutrition intervention or placebo group (75 per group). The nutrition intervention group will receive a theory based education and skill building intervention designed to decrease dietary sodium intake to ~2 g per day. A research nurse will make 4 home visits and one follow-up telephone call over 6 months to provide the education-skill building intervention. The intervention group will take 3 omega-3 fatty acid capsules (350 mg eicosahexaenoic acid and 50 mg docosahexaenoic acid) and consume tomato juice or other tomato-based products containing 20-25 mg of lycopene daily for six months. The placebo group will receive the same number of visits and phone calls but only general nutrition information will be provided. They will take 3 placebo capsules containing soybean oil (500 mg/capsule) and consume their choice of fruit juices that do not contain lycopene daily for six months. Data will be collected in person at baseline, 3 months, and 6 months by a research assistant blinded to the group assignment. Patients will be followed for an additional 6 months by telephone to collect longer term data on symptom burden and quality of life as well as heart failure hospitalization and all-cause mortality at 9 and 12 months.