NCT02568930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
694

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

October 15, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

February 16, 2022

Status Verified

November 1, 2021

Enrollment Period

5.5 years

First QC Date

October 2, 2015

Last Update Submit

February 14, 2022

Conditions

Heart Failure

Keywords

quality of life heart failure mechanical support transplant

Outcome Measures

Primary Outcomes (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.

    baseline through 2 years after surgery

Secondary Outcomes (5)

  • Non-inferior change in caregiver HRQOL

    baseline through 2 years after surgery

  • Risk factors related to poorer patient overall HRQOL

    2 years after surgery

  • Risk factors related to poorer caregiver overall HRQOL

    2 years after surgery

  • Non-inferior rates of freedom from adverse events & symptoms

    1 and 2 years after surgery

  • Distribution of QALYs

    2 years after surgery

Study Arms (2)

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.

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Advanced HF and listed with the United Network for Organ Sharing (UNOS) for a "primary" HT or scheduled to receive a "primary" DT LVAD;
  • Ages 60-80 years and able to speak, read, and understand English;
  • Willing to participate and ability to provide informed consent.
  • Primary caregiver, identified by the patient, prior to DT MCS or while a candidate for HT;
  • Unpaid family member or friend who helps the patient with self-care;
  • Age \> 21 years and able to speak, read, and write English;
  • Willing to participate and ability to provide informed consent.

You may not qualify if:

  • Patient has a prior HT or MCS device
  • Patient is listed for multiple organ transplantation (i.e., heart/lung, heart/kidney, etc.)
  • \) Patient refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35294, United States

Location

Florida Hospital

Orlando, Florida, 32803-1248, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota Medical Center-Fairview Health Services

Minneapolis, Minnesota, 55454, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Columbia University

New York, New York, 10032-3702, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University (OSU)

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53706-1490, United States

Location

Related Publications (5)

  • 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.

    PMID: 38910557DERIVED

  • 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.

    PMID: 37345518DERIVED

  • 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.

    PMID: 37088337DERIVED

  • 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.

    PMID: 36214123DERIVED

  • 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.

    PMID: 35156421DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Kathleen Grady, RN, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Feinberg School of Medicine

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 6, 2015

Study Start

October 15, 2015

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

February 16, 2022

Record last verified: 2021-11

Locations

US(13)