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

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ClinicalTrials.gov Identifier: NCT02568930
Recruitment Status : Active, not recruiting
First Posted : October 6, 2015
Last Update Posted : March 6, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kathleen Grady, Northwestern University

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: SUSTAIN-IT: Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support?
Study Start Date : July 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Non-inferior change in patient HRQOL [ Time Frame: baseline through 2 years after surgery ]
    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.


Secondary Outcome Measures :
  1. Non-inferior change in caregiver HRQOL [ Time Frame: baseline through 2 years after surgery ]
    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.

  2. Risk factors related to poorer patient overall HRQOL [ Time Frame: 2 years after surgery ]
    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.

  3. Risk factors related to poorer caregiver overall HRQOL [ Time Frame: 2 years after surgery ]
    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.

  4. Non-inferior rates of freedom from adverse events & symptoms [ Time Frame: 1 and 2 years after surgery ]
    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.

  5. Distribution of QALYs [ Time Frame: 2 years after surgery ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568930


Locations
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United States, Alabama
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35294
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803-1248
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota Medical Center-Fairview Health Services
Minneapolis, Minnesota, United States, 55454
United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia University
New York, New York, United States, 10032-3702
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
The Ohio State University (OSU)
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53706-1490
Sponsors and Collaborators
Northwestern University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Kathleen Grady, RN, PhD Northwestern University
  Study Documents (Full-Text)

Documents provided by Kathleen Grady, Northwestern University:
Informed Consent Form  [PDF] August 31, 2018

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Responsible Party: Kathleen Grady, Professor, Feinberg School of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT02568930    
Other Study ID Numbers: STU00200851
1R01AG047416 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Keywords provided by Kathleen Grady, Northwestern University:
quality of life heart failure mechanical support transplant
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases