HF-ACTION

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 心衰-ACTION研究是一项多中心、前瞻性、随机化的临床试验，研究了常规护理加运动训练与常规护理在预防全因死亡率或住院方面的对比，研究对象为3000名NYHA II级、III级或IV级心衰且EF&lt；35%的患者。联合国维和行动中心将努力招收30名病人。主要目的是测试这样一种假设，即在常规护理的基础上接受运动训练的左心室收缩功能障碍和NYHA II-IV级症状的患者，在两年内的死亡率和住院率将比仅接受常规护理的患者低20%。第二个假设是，与运动训练相关的风险大于收益，干预将显著提高运动耐受性，干预将显著改善生活质量，并且干预将在经济上具有吸引力(节省成本或物有所值)。为了使研究结果具有广泛的适用性，我们选择了研究人群。基本上，任何符合纳入和排除标准的18岁或18岁以上转介试验的合格患者都将符合资格。为了保护高危患者，一个例外是要求完成基线运动测试时没有明显的运动引起的心律失常或明显的新的缺血。纳入标准为LVEF&lt；35%；尽管至少接受了6周治疗，但在前三个月内仍有NYHA II、III或IV级心力衰竭；必须根据AHA/ACC和HFSA心力衰竭指南接受最佳心力衰竭治疗，包括使用ACEI和β-受体阻滞剂治疗，或有记录的变异理由；根据研究人员的判断，必须足够稳定，才能开始锻炼计划。排除标准是：在研究期间短期无法参加运动训练计划，怀孕或打算怀孕，在过去6周内发生重大心血管事件，因任何原因计划在未来进行心血管手术或住院，未纠正的瓣膜疾病，先天性心脏病或梗阻性心肌病继发性心衰，阻碍达到目标运动心率的起搏器。患者将从心力衰竭诊所的患者登记中挑选出来。患者将进行超声心动图、6分钟步行试验和CPX试验。后者将在整个研究过程中重复几次。患者将被随机分为常规护理组或常规护理加运动训练组。最初，后者将在心脏康复股有36次受监督的培训课程。在此之后，他们将获得一台跑步机或健身自行车，免费提供，并可能在试验结束后保留。将有定期的监督培训课程。血液将被提取一次，并被送往杜克大学研究所，在那里它将被保存并用于尚未决定的生物标记物的研究。知情同意将根据各自机构和新墨西哥大学人权委员会制定的规则和条例获得。保密性将以被接受的方式到期。所有数据将被转发到杜克大学的临床研究中心，数据库将在那里进行维护和统计分析。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The HF-ACTION study is a multicenter, prospective, randomized clinical trial of Usual care plus Exercise Training versus Usual Care for the prevention of all-cause mortality or hospitalization in 3,000 patients with NYHA class II, III, or IV HF and EF < 35%. The UNMH Center will endeavor to enter 30 patisnts. The primary objective is to test the hypothesis that patients with LV systolic dysfunction and NYHA class II-IV symptoms who are given exercise training in addition to usual care will have a 20% lower rate of death and hospitalization over two years than patients who receive usual care alone. Secondary hypotheses are, that the risks associated with exercise training are outweighed by the benefits, that the intervention will significantly improve exercise tolerance, that the intervention will significantly improve the quality of life, and that the intervention will be economically attractive (cost saving or a reasonable value for money). The study population has been chosen to achieve a wide applicability of the results. Basically, any qualifying patient age 18 years or older referred to the trial who meets the inclusion and exclusion criteria will be eliglble. To protect high-risk patients, one exception is the requirement of completing a baseline exercise test without significant exercise-induced arrhythmia or significant new ischemia. The inclusion criteria are a LVEF <35%; NYHA class II, III, or IV heart failure for the previous three months despite a minimum of 6 weeks of treatment; must be on optimal heart failure therapy according to AHA/ACC and HFSA heart failure guidelines, including treatment with ACEI and beta-blocker therapy, or have documented rationale for variation; must be sufficiently stable, by investigator judgment, to begin an exercise program. The exclusion criteria are ain short inability to participate in an exercise training program for the duration of the study, pregnancy or intent to become pregnant, major cardiovascular event in the prior 6 weeks, a cardiovascular procedure or hospitalization for any reason planned in the future, uncorrected valvular disease, HF secondary to congenital heart disease or obstructive cardiomyopathy, pacemakers which prevent attainment of target exercise heart rate. Patients will be selected from the registry of patients in the Heart Failure Clinic. The patients will have an echocardiogram, will do a 6-minute walk test, and a CPX test. The latter will be repeated several times throughout the study. Patients will be randomized to Usual Care only or Usual Care plus exercise Training. Initially, the latter group will have 36 supervised training sessions in the Cardiac Rehabilitation Unit. After this they will be supplied with a treadmill or exercise bicycle which will be supplied free of charge and may be kept after the trial closes. There will be periodic supervised training sessions. Blood will be drawn once and sent to the Duke University Research Institute where it will be kept and used for studies of biomarkers yet to be decided upon. Informed consent will be obtained in accordance with the rules and regulations laid down by the respective institutions and the University of New Mexico's HRRC. Confidentiality will be matintained in the accepted manner. All data will be forwarded to Duke's Clinical research center where the database will be maitained and statistical analyses done.