Clinical Trials Logo
  1. Home
  2. Congestive Heart Failure (CHF)
  3. NCT00734045
  4. Details
NCT00734045 Clinical Trial

Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples

Congestive Heart Failure (CHF) Clinical Trial

— WB-13  

Official title:
Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00734045
Other study ID # WB-13
Secondary ID
Status Completed
Phase N/A
First received August 11, 2008
Last updated December 8, 2008
Start date February 2008
Est. completion date November 2008

Study information
Verified date December 2008
Source Nanogen, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 45 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Be 45 years of age or younger

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States US Department of Veteran's Affairs San Diego California
United States San Francisco General Hospital San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Nanogen, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary StatusFirst CHF NT-proBNP test result At presentation to study site (no follow-up) No
See also
  Status Clinical Trial Phase
Terminated NCT01831713 - Pulmonary Blood Flow Measurements in CHF Patients N/A
Withdrawn NCT01744210 - Evaluation of Blood Flow Patterns in Lung Blood Vessels Using Ultrasound Technique in Patients With Congestive Heart Failure N/A
Completed NCT00211874 - Improving Heart Failure Care in Minority Communities N/A
Completed NCT01960907 - Clinical Trials for Elderly Patients With Multiple Disease N/A
Terminated NCT00406575 - Recombinant Human Relaxin for the Treatment of Decompensated CHF Phase 2
Completed NCT00309764 - CHF Management Using Telemedicine N/A
Completed NCT02034045 - Expanding Paramedicine in the Community N/A
Completed NCT01855022 - A Trial to Reduce Readmissions Using Motivational Interviewing and Interactive Voice Response N/A
Completed NCT02983812 - Developing Enhanced Prediction Models
Completed NCT01044290 - Outlook Quality of Life Intervention Study N/A
Not yet recruiting NCT01414439 - Group Psychotherapy Among Congestive Heart Failure Patients N/A
Approved for marketing NCT00528320 - Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System N/A