SUSTAIN-IT: Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support? (SUSTAIN-IT)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure

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.

• Study Type: Observational
• Enrollment (Actual): 694

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham (UAB)
  • Florida
    • Orlando, Florida, United States, 32803-1248
      • Florida Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Medical Center-Fairview Health Services
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • New York, New York, United States, 10032-3702
      • Columbia University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University (OSU)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center (UPMC)
  • Wisconsin
    • Madison, Wisconsin, United States, 53706-1490
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Patient Inclusion Criteria:

1. Advanced HF and listed with the United Network for Organ Sharing (UNOS) for a "primary" HT or scheduled to receive a "primary" DT LVAD;
2. Ages 60-80 years and able to speak, read, and understand English;
3. Willing to participate and ability to provide informed consent.

Caregiver Inclusion criteria:

1. Primary caregiver, identified by the patient, prior to DT MCS or while a candidate for HT;
2. Unpaid family member or friend who helps the patient with self-care;
3. Age > 21 years and able to speak, read, and write English;
4. Willing to participate and ability to provide informed consent.

Patient Exclusion criteria

1. Patient has a prior HT or MCS device
2. Patient is listed for multiple organ transplantation (i.e., heart/lung, heart/kidney, etc.)

Caregiver Exclusion criterion:

1) Patient refusal to participate.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Heart Transplantation (HT); The cohort includes advanced heart failure patients (60-80 years of age) listed for HT and their caregivers.
Mechanical Circulatory Support (MCS); The cohort includes advanced heart failure patients (60-80 years of age) scheduled for DT MCS and their caregivers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferior change in patient HRQOL	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 outcome) and HRQOL domains (physical, mental, and social [secondary outcomes]) from baseline through 2 years after surgery.	baseline through 2 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferior change in caregiver HRQOL	To determine whether caregivers of older advanced HF patients who undergo DT MCS, as compared to caregivers of older advanced HF patients who undergo HT, experience non-inferior change in overall HRQOL and HRQOL domains from baseline through 2 years after surgery.	baseline through 2 years after surgery
Risk factors related to poorer patient overall HRQOL	To identify risk factors related to poorer overall HRQOL in older DT MCS patients, as compared to older HT patients, at 2 years after surgery.	2 years after surgery
Risk factors related to poorer caregiver overall HRQOL	To identify risk factors related to poorer overall HRQOL in caregivers of older DT MCS patients, as compared to caregivers of older HT patients, at 2 years after surgery.	2 years after surgery
Non-inferior rates of freedom from adverse events & symptoms	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 & 2 years after surgery.	1 and 2 years after surgery
Distribution of QALYs	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.	2 years after surgery

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Kathleen Grady, RN, PhD, Northwestern University

Publications and helpful links

General Publications

• Grady KL, Kao A, Spertus JA, Hsich E, Dew MA, Pham DT, Hartupee J, Petty M, Cotts W, Pamboukian SV, Pagani FD, Lampert B, Johnson M, Murray M, Takeda K, Yuzefpolskaya M, Silvestry S, Kirklin JK, Andrei AC, Elenbaas C, Baldridge A, Yancy C. Health-Related Quality of Life in Older Patients With Heart Failure From Before to Early After Advanced Surgical Therapies: Findings From the SUSTAIN-IT Study. Circ Heart Fail. 2022 Oct;15(10):e009579. doi: 10.1161/CIRCHEARTFAILURE.122.009579. Epub 2022 Oct 10.
• Grady KL, Andrei AC, Elenbaas C, Warzecha A, Baldridge A, Kao A, Spertus JA, Pham DT, Dew MA, Hsich E, Cotts W, Hartupee J, Pamboukian SV, Pagani FD, Petty M, Lampert B, Johnson M, Murray M, Takeda K, Yuzefpolskaya M, Silvestry S, Kirklin JK, Yancy C. Health-Related Quality of Life in Older Patients With Advanced Heart Failure: Findings From the SUSTAIN-IT Study. J Am Heart Assoc. 2022 Feb 15;11(4):e024385. doi: 10.1161/JAHA.121.024385. Epub 2022 Feb 12.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2015
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: October 2, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 6, 2015

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: quality of life heart failure mechanical support transplant
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: STU00200851; 1R01AG047416 (U.S. NIH Grant/Contract)