Blood Collection From Heart Failure Patients to Evaluate for Galectin-3 Measurement Differences Using Various Collection Tubes

August 4, 2014 updated by: Fujirebio Diagnostics, Inc.
Single-site blood collection investigation.

Study Overview

Status

Completed

Conditions

Detailed Description

45 Heart Failure patients will be recruited. Patients will provide a one-time blood sample specimen collection. Theses samples will be de-identified and provided for measurement of Galectin-3 on commercial platforms.

Study Type

Observational

Enrollment (Actual)

48

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
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

45 matched door serum and plasma. Samples set collected form individual Heart Failure patients for galecin-3 measurements

Description

Inclusion Criteria:

  • Heart Failure patients New York Heart Association class able to provide (4) collection tube types Subjects > 18 years old All subjects must provide informed consent and associated documentation

Exclusion Criteria:

  • Subjects that cannot tolerate blood withdrawal of 4 specimens collection tube tubes (approximately 40 mLs)

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
Heart Failure patients
No interventions for this study. Blood draw provided by patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Obtain 45 matched donor serum and plasma samples sets collected from Heart Failure patients for galectin-3 measurements
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Fujirebio Diagnostics, Inc.

Investigators

  • Principal Investigator: Robert Christenson, MD, Universtiy of Maryland School of Medicine

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

August 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDI-83

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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