Characterization of the Plasma Proteome Following Left Ve... | NCT02428894

Studies
Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation

NCT02428894

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

Jul 17, 2017Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Ventricular Dysfunction, Left

Interventions

LVAD

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
14GRNT20380495	Other Grant/Funding Number	American Heart Association

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Apr 17, 2015

First Submission Date that Met QC Criteria

Apr 23, 2015

First Posted Date

Apr 29, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2017

Last Update Posted Date

Jul 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Label	Type	Description	Intervention Names
LVAD recipients			Device: LVAD

Name	Type	Description	Arm Group Labels	Other Names
LVAD	Device		LVAD recipients	HeartMate II

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christina Aquilante, Pharm.D.	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Anschutz Medical Campus		Aurora	Colorado	80045	United States

Condition Browse Module

MeSH Terms

ID	Term
D018487	Ventricular Dysfunction, Left

Ancestor Terms

ID	Term
D018754	Ventricular Dysfunction
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided