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

Systolic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156583
• Other study ID #: 14C.146
• Status: Completed
• First received: June 3, 2014
• Last updated: April 6, 2018
• Start date: May 2014
• Est. completion date: July 2017

Study information

• Verified date: April 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Systolic Heart Failure

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Thomas Jefferson University	Greater New York Geriatric Cardiology Consortium, National Skeletal Muscle Research Center, Thoratec Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Maurer MS, Horn E, Reyentovich A, Dickson VV, Pinney S, Goldwater D, Goldstein NE, Jimenez O, Teruya S, Goldsmith J, Helmke S, Yuzefpolskaya M, Reeves GR. Can a Left Ventricular Assist Device in Individuals with Advanced Systolic Heart Failure Improve or — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive function measured by the Montreal Cognitive Assessment		Baseline; 3 and 6 months post-operatively
Primary	Change in frailty following left ventricular assist device implantation	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	Skeletal muscle size as measured by ultrasonography		Baseline (prior to surgery); 10 days and 3 months postoperatively