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Completed

NCT Number: NCT02428894

Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation

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

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Key information

Conditions

Ventricular Dysfunction, Left Cardiovascular Diseases Heart Diseases Ventricular Dysfunction

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LVAD

Device

Other names: HeartMate II

Primary outcomes

  1. Quantitative differences in plasma protein abundance

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2015
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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