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OpenTrials
Completed

NCT Number: NCT02156583

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

This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy.

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Key information

Conditions

Systolic Heart Failure Cardiovascular Diseases Frailty Heart Diseases Heart Failure Heart Failure, Systolic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Skeletal muscle size as measured by ultrasonography

    Time frame: Baseline (prior to surgery); 10 days and 3 months postoperatively

Other outcomes

  1. Cognitive function measured by the Montreal Cognitive Assessment

    Time frame: Baseline; 3 and 6 months post-operatively

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

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

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 5, 2014
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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