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Heart FailureSUSTAIN-ITNCT02568930

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

An observational study of Heart Failure, run by Northwestern University at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Heart Failure
How many people
694 participants
Where
13 sitesUnited States
Study dates
15 Oct 2015to 31 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35294

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University (OSU)

    Columbus, Ohio, 43210

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53706-1490

  • University of Minnesota Medical Center-Fairview Health Services

    Minneapolis, Minnesota, 55454

  • Columbia University

    New York, New York, 10032-3702

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Florida Hospital

    Orlando, Florida, 32803-1248

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15213

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Read the 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.

Conditions
Heart Failure
Keywords
quality of life heart failure mechanical support transplant
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02568930
Study groupRoleWhat they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline through 2 years after surgery

Secondary outcomes (5)

  1. 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.

    Measured: baseline through 2 years after surgery

  2. 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.

    Measured: 2 years after surgery

  3. 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.

    Measured: 2 years after surgery

  4. 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.

    Measured: 1 and 2 years after surgery

  5. 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.

    Measured: 2 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2015 (estimated)
  2. Study start15 Oct 2015
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
694 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02568930
Sponsor's protocol ID
STU00200851
Other IDs
1R01AG047416
Acronym
SUSTAIN-IT
Status last verified
Nov 2021
First submitted
2 Oct 2015
Last updated
16 Feb 2022
Results posted
No
Data monitoring committee
No

Publications

  • Nguyen DD, Spertus JA, Benton MC, Thomas M, Jones PG, Andrei AC, Wu T, Baldridge AS, Grady KL. Association of Patient Reported Outcomes With Caregiver Burden in Older Patients With Advanced Heart Failure: Insights From the SUSTAIN-IT Study. Circ Heart Fail. 2024 Jul;17(7):e011705. doi: 10.1161/CIRCHEARTFAILURE.124.011705. Epub 2024 Jun 24.

    PubMed 38910557

  • Grady KL, Dew MA, Pagani FD, Spertus JA, Hsich E, Yuzefpolskaya M, Lampert B, Kirklin JK, Petty M, Kao A, Yancy C, Hartupee J, Pamboukian SV, Johnson M, Murray M, Wu T, Andrei AC. A comparison of quality-adjusted life years in older adults after heart transplantation versus long-term mechanical support: Findings from the SUSTAIN-IT study. J Heart Lung Transplant. 2024 Sep;43(9):1422-1433. doi: 10.1016/j.healun.2024.05.008. Epub 2024 May 17.

    PubMed 38762215

  • Chuzi S, Wilcox JE, Kao A, Spertus JA, Hsich E, Dew MA, Yancy CW, 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, Wu T, Andrei AC, Baldridge A, Grady KL. Change in Caregiver Health-Related Quality of Life From Before to Early After Surgery: SUSTAIN-IT Study. Circ Heart Fail. 2023 Aug;16(8):e010038. doi: 10.1161/CIRCHEARTFAILURE.122.010038. Epub 2023 Jun 22.

    PubMed 37345518

  • Okwuosa IS, Anderson A, Petty M, Wu T, Andrei AC, Kao A, Spertus JA, Pham DT, Yancy CW, Dew MA, Hsich E, Cotts W, Hartupee J, Pamboukian S, Pagani F, Lampert B, Johnson M, Murray M, Tekeda K, Yuzefpolskaya M, Kirklin JK, Grady KL. Caregiver burden before heart transplantation and long-term mechanical circulatory support: Findings from the sustaining quality of life of the aged: Transplant or mechanical support (SUSTAIN-IT) study. J Heart Lung Transplant. 2023 Sep;42(9):1197-1204. doi: 10.1016/j.healun.2023.01.015. Epub 2023 Apr 21.

    PubMed 37088337

  • 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.

    PubMed 36214123

  • 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.

    PubMed 35156421

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Northwestern University at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-inferior change in patient HRQOL (time frame: baseline through 2 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02568930, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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