Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation

July 14, 2017 updated by: University of Colorado, Denver
The purpose of this study is to characterize changes in the plasma proteome over time following left ventricular assist device (LVAD) implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

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

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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
Intervention / Treatment
LVAD recipients
Device: LVAD
Other Names:
  • HeartMate II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantitative differences in plasma protein abundance
Time Frame: Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation
Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Christina Aquilante, Pharm.D., University of Colorado, Denver

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

October 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

April 17, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Actual)

July 17, 2017

Last Update Submitted That Met QC Criteria

July 14, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1376
  • 14GRNT20380495 (Other Grant/Funding Number: American Heart Association)

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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