Clinical trial NCT02568930: SUSTAIN-IT: Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support?
Official title: SUSTAIN-IT: Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: quality of life heart failure mechanical support transplant
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2015-10-06
Enrollment: 694
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Non-inferior change in patient HRQOL
timeFrame: baseline through 2 years after surgery
Secondary outcomes:
measure: Non-inferior change in caregiver HRQOL
timeFrame: baseline through 2 years after surgery
measure: Risk factors related to poorer patient overall HRQOL
timeFrame: 2 years after surgery
measure: Risk factors related to poorer caregiver overall HRQOL
timeFrame: 2 years after surgery
measure: Non-inferior rates of freedom from adverse events & symptoms
timeFrame: 1 and 2 years after surgery
measure: Distribution of QALYs
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB)
state: Alabama
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center-Fairview Health Services
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Columbia University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University (OSU)
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: Northwestern University
name: Kathleen Grady, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.