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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG047416 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Patient Inclusion Criteria:
Caregiver Inclusion criteria:
Patient Exclusion criteria
Caregiver Exclusion criterion:
1) Patient refusal to participate.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Grady, RN, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35294 | United States | ||
| Florida Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38910557 | Derived | 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. | |
| 37345518 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2018 | Aug 20, 2019 |
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| 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 |
| Orlando |
| Florida |
| 32803-1248 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota Medical Center-Fairview Health Services | Minneapolis | Minnesota | 55454 | United States |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Columbia University | New York | New York | 10032-3702 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University (OSU) | Columbus | Ohio | 43210 | United States |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Wisconsin-Madison | Madison | Wisconsin | 53706-1490 | United States |
| 37088337 | Derived | 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. |
| 36214123 | Derived | 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. |
| 35156421 | Derived | 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. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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