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

Sponsor
Thomas Jefferson University (Other)
Overall Status
Completed
CT.gov ID
NCT02156583
Collaborator
Thoratec Corporation (Industry), National Skeletal Muscle Research Center (Other), Greater New York Geriatric Cardiology Consortium (Other)
20
Enrollment
1
Location
38
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients
    Actual Study Start Date :
    May 1, 2014
    Actual Primary Completion Date :
    Jul 1, 2017
    Actual Study Completion Date :
    Jul 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Older, left ventricular assist device

    Older heart failure patients undergoing left ventricular assist device implantation

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

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

    Other Outcome Measures

    1. Cognitive function measured by the Montreal Cognitive Assessment [Baseline; 3 and 6 months post-operatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Thomas Jefferson University
    • Thoratec Corporation
    • National Skeletal Muscle Research Center
    • Greater New York Geriatric Cardiology Consortium

    Investigators

    • Principal Investigator: Gordon R Reeves, MD, MPT, Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT02156583
    Other Study ID Numbers:
    • 14C.146
    First Posted:
    Jun 5, 2014
    Last Update Posted:
    Apr 10, 2018
    Last Verified:
    Apr 1, 2018
    Keywords provided by Thomas Jefferson University
    Ventricular Assist Device
    Skeletal Muscle
    Frailty
    Older adults
    Additional relevant MeSH terms:
    Heart Failure
    Heart Failure, Systolic
    Frailty

    Study Results

    No Results Posted as of Apr 10, 2018