NCT00734045

Brief Summary

The primary objective of the study is to establish the correlation between NT-proBNP measurements in fresh human whole blood samples and those in plasma samples from the same study subjects, where said samples are collected in EDTA and Li-Hep anticoagulant tubes and measured by the StatusFirst™ CHF NT-proBNP device in conjunction with the DXpressTM Reader in a laboratory setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 10, 2008

Status Verified

December 1, 2008

Enrollment Period

9 months

First QC Date

August 11, 2008

Last Update Submit

December 8, 2008

Conditions

Congestive Heart Failure (CHF)

Keywords

Congestive Heart Failure (CHF)NT-proBNP

Outcome Measures

Primary Outcomes (1)

  • StatusFirst CHF NT-proBNP test result

    At presentation to study site (no follow-up)

Study Arms (2)

1

Subjects with diagnosed congestive heart failure

2

Subjects not diagnosed with congestive heart failure

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients to be recruited for the study should either: * have clinically confirmed heart failure (NYHA class I-IV) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, OR * be non-CHF controls greater than 45 years of age with no history of heart failure or cardiovascular disease.

You may qualify if:

  • Have clinically confirmed heart failure (NYHA class I-IV) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, OR
  • Be non-CHF controls greater than 45 years of age with no history of heart failure or cardiovascular disease.

You may not qualify if:

  • Be 45 years of age or younger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

US Department of Veteran's Affairs

San Diego, California, 92161, United States

Location

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Alan Wu, PhD

    University of California San Francisco and San Francisco General Hospital

    PRINCIPAL INVESTIGATOR

  • Alan Maisel, MD

    University of California San Diego; Veteran's Affairs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

February 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 10, 2008

Record last verified: 2008-12

Locations

US(2)