SUSTAIN-IT: Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support?
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The purpose of this study is to compare health-related quality of life (HRQOL) outcomes in
      older (60-80 years) advanced heart failure (HF) patients who undergo heart transplantation
      (HT) or mechanical circulatory support (MCS) as a permanent implant (i.e., destination
      therapy [DT]) and their caregivers. Our study will contribute to better patient-centered care
      of older advanced HF patients and their caregivers, by informing decision making and guiding
      strategies to enhance post-operative HRQOL.
    

Detailed description: 
      The purpose of this study is to compare health-related quality of life (HRQOL) outcomes in
      older (60-80 years) advanced heart failure (HF) patients who undergo heart transplantation
      (HT) or mechanical circulatory support (MCS) as a permanent implant (i.e., destination
      therapy [DT]) and their caregivers, risk factors for poor HRQOL, adverse event and symptom
      burden, and quality-adjusted life years (QALYs). Advanced HF patients, 60-80 years of age,
      are an appropriate target group for this study because they are receiving HTs and MCS devices
      more frequently, and despite a greater risk for poor clinical outcomes, they have acceptable
      rates of survival. Using a prospective, longitudinal design, our multi-site comparative
      effectiveness research will compare HRQOL outcomes in patients who receive HT or DT MCS and
      their caregivers, from baseline to 2 years post-operatively. The primary aim of this proposed
      study is to determine whether older advanced HF patients who undergo DT MCS, as compared to
      patients who undergo HT, experience non-inferior change in overall HRQOL (primary), and
      domains of HRQOL (physical, mental, and social) from baseline through 2 years after surgery.
      Secondary Aims are (1.) to determine whether caregivers of older advanced HF patients who
      undergo DT MCS, compared to caregivers of older advanced HF patients who undergo HT,
      experience non-inferior change in overall HRQOL and domains from baseline through 2 years
      after surgery; (2.-3.) to identify risk factors related to poorer overall HRQOL in older DT
      MCS patients and their caregivers, as compared to older HT patients and their caregivers, at
      2 years after surgery; (4.) to determine whether older advanced HF patients who undergo DT
      MCS, as compared to patients who undergo HT, have non-inferior rates of freedom from adverse
      events & symptoms at 1 and 2 years after surgery; and (5) to evaluate the distribution of
      QALYs in older advanced HF patients who undergo DT MCS, as compared to patients who undergo
      HT at 2 years after surgery. Our proposed study will contribute to better patient-centered
      care of older advanced HF patients and their caregivers, by informing decision making and
      guiding strategies to enhance post-operative HRQOL.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes advanced heart failure patients (60-80 years of age)
        scheduled for DT MCS and their caregivers and advanced heart failure patients (60-80 years
        of age) listed for HT and their caregivers.
      
Keywords: quality of life heart failure mechanical support transplant