The Impact of Race on Quality of Life of the Aged after Heart Transplant or Destination Therapy Mechanical Support

本研究的目的是确定老年晚期心力衰竭（HF）患者 接受目的治疗机械循环支持（DT MCS）的患者，与 接受心脏移植（HT）的患者，在总体上经历了非劣效性变化， 健康相关生活质量（HRQOL）和HRQOL领域（身体、精神和社会）， 从基线到术后1年的比赛。晚期HF患者，60-80岁，是一个 本拟议研究的适当目标人群，因为他们正在接受HT和植入 MCS器械使用频率更高，尽管临床结局较差的风险更大， 可接受的生存率。虽然研究已经检查了总生存率，但很少有人考虑到 接受HT或DT MCS的老年少数患者的HRQOL。我建议的研究可以 通过告知，有助于更好地以患者为中心的老年少数晚期HF患者护理 决策和指导策略，以提高术后HRQOL。我会利用 维持老年人生活质量的数据资源：心脏移植或机械 支援？（SUSTAIN-IT）（国家老龄化研究所#R 01 AG 047416，2015年7月15日至2021年3月31日）。 SUSTAIN-IT是一项多中心、观察性、前瞻性、纵向、比较有效性 study.我将使用一个理论框架来模拟疾病，治疗， 不良事件和症状，以指导这项拟议的研究。主要目的是 确定与接受DT MCS的患者相比， 接受HT（伴或不伴MCS）的患者的总体HRQOL发生非劣效性变化 （主要终点，使用心力衰竭特异性堪萨斯城心肌病-12问卷 总评分）和按人种（白色与所有少数民族）列出的HRQOL领域 术后一年。第二个目的是确定种族是否是一个风险因素， 总体HRQOL（使用堪萨斯城心肌病-12心力衰竭特定问卷 总评分作为因变量），对于1年时接受DT MCS和HT的患者 手术后。

The purpose of this study is to determine whether older advanced heart failure (HF) patients who undergo destination therapy mechanical circulatory support (DT MCS), as compared to patients who undergo heart transplantation (HT), experience non-inferior change in overall health-related quality of life (HRQOL) and HRQOL domains (physical, mental, and social) by race from baseline to 1 year post-operatively. Advanced HF patients, 60-80 years of age, are an appropriate target group for this proposed study because they are receiving HTs and implant of MCS devices more frequently, and despite a greater risk for poor clinical outcomes, they have acceptable rates of survival. While studies have examined overall survival, few have considered HRQOL of older minority patients who undergo HT or DT MCS. MY proposed study may contribute to better patient-centered care of older minority advanced HF patients, by informing decision making and guiding strategies to enhance post-operative HRQOL. I will leverage the data resources of Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support? (SUSTAIN-IT) (National Institute on Aging # R01AG047416, 7/15/15 – 3/31/21). SUSTAIN-IT is a multi-site, observational, prospective, longitudinal, comparative effectiveness study. I will use a theoretical framework which models the influence of disease, treatment, adverse events, and symptoms on HRQOL to guide this proposed study. The primary aim is to determine whether older advanced HF patients who undergo DT MCS, as compared to patients who undergo HT (with or without MCS) experience non-inferior change in overall HRQOL (primary endpoint, using the heart failure-specific Kansas City Cardiomyopathy-12 questionnaire summary score), and HRQOL domains by race (white versus all minorities) from baseline to 1 year post-operatively. The secondary Aim is to determine whether race is a risk factor related to overall HRQOL (using the Kansas City Cardiomyopathy-12 heart-failure specific questionnaire summary score as the dependent variable), for patients who undergo DT MCS and HT at 1 year post-operatively.