Heart Failure (HF) Assessment With B-type Natriuretic Peptide (BNP) In The Home
NCT ID: NCT00946231
Last Updated: 2012-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
187 participants
OBSERVATIONAL
2009-07-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Heart Failure
Subjects admitted to the hospital with decompensated heart failure.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Admitted to the hospital or observation unit with a diagnosis of decompensated HF for which treatment will be administered;
* Blood BNP level measurement \> 400 pg/mL documented during admission; If NT-proBNP is used routinely in the laboratory at a clinical site rather than BNP, then blood NT-proBNP level measurement \> 1,600 pg/mL documented during admission.
* Successfully trained on how to perform a fingerstick and to use the Triage touch.
* Either the subject or their care provider is fluent in reading and writing English
Exclusion Criteria
* Acute coronary syndrome (ACS) that is concomitant with the diagnosis of decompensated HF and for which treatment will be provided.
A history of ACS is not reason for exclusion if it is not concomitant with the present decompensated HF for which admission is being made. Small elevations in cardiac troponin that are considered by the treating physician to be associated with myocardial injury due to the acute decompensated HF and not due to a concomitant ACS or myocardial infarction are not a basis for exclusion.
* Previous cardiac transplantation - or cardiac transplantation anticipated within 3 months;
* Current or planned use of a left ventricular assist device (LVAD), use of outpatient intravenous inotropic HF therapy, major surgical procedure or percutaneous coronary intervention within 3 months;
* Life expectancy less than 3 months due to causes other than HF or cardiovascular disease (e.g., cancer);
* End stage renal disease;
* Prisoner or other institutionalized or vulnerable individual;
* Residence in regions where either transmission of Triage Touch data or a home visit on day 5 is not possible.
* Dementia, tremors or other impediments to performing daily home BNP testing via fingerstick.
* Deemed by the Investigator not to be likely to comply with study-mandated procedures or instructions.
18 Years
ALL
No
Sponsors
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Inverness Medical Innovations
INDUSTRY
Abbott RDx Cardiometabolic
OTHER
Responsible Party
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Biosite Incorporated
Principal Investigators
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Alan S Maisel, MD
Role: PRINCIPAL_INVESTIGATOR
Veterans Affairs San Diego Healthcare System
Locations
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Care Clinical Research Corp DBA Beaver Medical Center
Banning, California, United States
Scripps Clinic Torrey Pines
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Loma Linda VA Medical Center
Loma Linda, California, United States
Mission Internal Medical Group
Mission Viejo, California, United States
St. Josephs Hospital
Orange, California, United States
University of California Irvine Medical Center
Orange, California, United States
Desert Cardiology Center
Rancho Mirage, California, United States
UCSD Medical Center
San Diego, California, United States
San Diego Cardiac Center
San Diego, California, United States
VA- UCSD
San Diego, California, United States
Countries
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References
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Maisel A, Barnard D, Jaski B, Frivold G, Marais J, Azer M, Miyamoto MI, Lombardo D, Kelsay D, Borden K, Iqbal N, Taub PR, Kupfer K, Clopton P, Greenberg B. Primary results of the HABIT Trial (heart failure assessment with BNP in the home). J Am Coll Cardiol. 2013 Apr 23;61(16):1726-35. doi: 10.1016/j.jacc.2013.01.052. Epub 2013 Mar 26.
Other Identifiers
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BSTE-0108
Identifier Type: -
Identifier Source: org_study_id