Systolic Heart Failure
Conditions
Keywords
Ventricular Assist Device, Skeletal Muscle, Frailty, Older adults
Brief summary
This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy.
Interventions
None listed
Sponsors
Thoratec Corporation
National Skeletal Muscle Research Center
Greater New York Geriatric Cardiology Consortium
Thomas Jefferson University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 60 years old or older * Scheduled to undergo left ventricular assist device implantation at Thomas Jefferson University
Exclusion criteria
* Unable or unwilling to provide informed consent * Unable to complete baseline frailty assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in frailty following left ventricular assist device implantation | Baseline (prior to surgery); 10 days, 1 month, 3 months, and 6 months post-operatively | Frailty will be assess based on the domains initially described by Fried and colleagues: weakness, low physical activity, unintentional weight loss, slowness and exhaustion. Additional frailty measures include the Short Physical Performance Battery (SPPB), as well as gait speed and hand grip strength as single item measures. |
Secondary
| Measure | Time frame |
|---|---|
| Skeletal muscle size as measured by ultrasonography | Baseline (prior to surgery); 10 days and 3 months postoperatively |
Other
| Measure | Time frame |
|---|---|
| Cognitive function measured by the Montreal Cognitive Assessment | Baseline; 3 and 6 months post-operatively |
Countries
United States
Outcome results
None listed