Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Ventricular Dysfunction, Left

Treatments: Device: LVAD

Study type: Observational

Funder types: Other

Identifiers

NCT02428894

14-1376

14GRNT20380495 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

LVAD recipients

Treatment:

Device: LVAD