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.
|Effective start/end date||9/1/21 → 5/31/23|
- National Institute on Aging (1R36AG073531-01)
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