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

April 6, 2018 updated by: Thomas Jefferson University
This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive heart failure patients 60 years old or older undergoing left ventricular assist device implantation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Older, left ventricular assist device
Older heart failure patients undergoing left ventricular assist device implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (prior to surgery); 10 days, 1 month, 3 months, and 6 months post-operatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Skeletal muscle size as measured by ultrasonography
Time Frame: Baseline (prior to surgery); 10 days and 3 months postoperatively
Baseline (prior to surgery); 10 days and 3 months postoperatively

Other Outcome Measures

Outcome Measure
Time Frame
Cognitive function measured by the Montreal Cognitive Assessment
Time Frame: Baseline; 3 and 6 months post-operatively
Baseline; 3 and 6 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

June 3, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14C.146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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