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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01980862
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):
Fujirebio Diagnostics, Inc.

Study Description
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Brief Summary:
Single-site blood collection investigation.

Condition or disease
To Measure Galectin-3 in Heart Failure Patients on Commercial Platforms

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Study Start Date : August 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort
Heart Failure patients
No interventions for this study. Blood draw provided by patients.


Outcome Measures
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Primary Outcome Measures :
  1. Obtain 45 matched donor serum and plasma samples sets collected from Heart Failure patients for galectin-3 measurements [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980862


Locations
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United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Fujirebio Diagnostics, Inc.
Investigators
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Principal Investigator: Robert Christenson, MD Universtiy of Maryland School of Medicine
More Information
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Additional Information:

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Responsible Party: Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT01980862    
Other Study ID Numbers: FDI-83
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases