Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation

Ventricular Dysfunction, Left Clinical Trial

Official title:

Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428894
• Other study ID #: 14-1376
• Secondary ID: 14GRNT20380495
• Status: Completed
• Phase: N/A
• First received: April 17, 2015
• Last updated: July 14, 2017
• Start date: October 2014
• Est. completion date: January 2017

Study information

• Verified date: July 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to characterize changes in the plasma proteome over time following left ventricular assist device (LVAD) implantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• Planned HeartMate II LVAD implantation

• Planned warfarin (goal INR, 2.0-3.0) and low-dose aspirin therapy post-LVAD placement

Exclusion Criteria:

• Prior history of mechanical circulatory support;

• Body weight < 110 lbs;

• Pre-existing hemolytic, bleeding, or immunologic disorders prior to LVAD implantation;

• Severe aortic stenosis;

• Renal failure requiring dialysis;

• Hepatic dysfunction resulting in severe coagulopathies;

• Recent serious infection;

• Current need for prolonged ventilatory support;

• Prior organ transplantation;

• Blood transfusion within 14 days of the first planned study blood draw;

• Concomitant immunosuppressant or chemotherapeutic agents;

• Pregnant women;

• Decisionally challenged or prisoners;

• Unwilling to provide written informed consent

Related Conditions & MeSH terms

• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• LVAD

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative differences in plasma protein abundance		Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation