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

Completed

• Conditions: Heart Failure

• Registration Number: NCT02568930
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-06
• Study Start: 2015-10-15
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-11
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 694

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.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Non-inferior change in patient HRQOL	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

Name	Time	Method
Non-inferior change in caregiver HRQOL	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.
Risk factors related to poorer patient overall HRQOL	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.
Risk factors related to poorer caregiver overall HRQOL	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.
Distribution of QALYs	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.
Non-inferior rates of freedom from adverse events & symptoms	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.

Trial Locations

Locations (13)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Minnesota Medical Center-Fairview Health Services; 🇺🇸 Minneapolis, Minnesota, United States

The Ohio State University (OSU); 🇺🇸 Columbus, Ohio, United States

University of Pittsburgh Medical Center (UPMC); 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Alabama at Birmingham (UAB); 🇺🇸 Birmingham, Alabama, United States

Florida Hospital; 🇺🇸 Orlando, Florida, United States

Advocate Christ Medical Center; 🇺🇸 Oak Lawn, Illinois, United States

Columbia University; 🇺🇸 New York, New York, United States

Saint Luke's Hospital; 🇺🇸 Kansas City, Missouri, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States