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Clinical Trials/NCT02156583
NCT02156583
Completed
Not Applicable

Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients

Thomas Jefferson University1 site in 1 country20 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Systolic Heart Failure
Sponsor
Thomas Jefferson University
Enrollment
20
Locations
1
Primary Endpoint
Change in frailty following left ventricular assist device implantation
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
July 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in frailty following left ventricular assist device implantation

Time Frame: 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 Outcomes

  • Skeletal muscle size as measured by ultrasonography(Baseline (prior to surgery); 10 days and 3 months postoperatively)

Study Sites (1)

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