NCT02428894

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

2.3 years

First QC Date

April 17, 2015

Last Update Submit

July 14, 2017

Conditions

Ventricular Dysfunction, Left

Outcome Measures

Primary Outcomes (1)

  • Quantitative differences in plasma protein abundance

    Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation

Study Arms (1)

LVAD recipients

Device: LVAD

Interventions

LVADDEVICE
Also known as: HeartMate II
LVAD recipients

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be recruited from the University of Colorado Hospital Advanced Heart Failure Program.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Change in plasma proteins. \[Time Frame, Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation\]\[Designated as safety issue: No\]

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • Christina Aquilante, Pharm.D.

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 29, 2015

Study Start

October 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 17, 2017

Record last verified: 2017-07

Locations

US(1)