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Heart Failure (HF) Assessment With B-type Natriuretic Peptide (BNP) In The Home (HABIT)

This study has been completed.
Sponsor:
Collaborator:
Inverness Medical Innovations
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00946231
First received: July 23, 2009
Last updated: August 30, 2012
Last verified: August 2012

July 23, 2009
August 30, 2012
July 2009
June 2011   (final data collection date for primary outcome measure)
To use the Triage touch to determine the optimal frequency of home BNP testing and the changes in BNP concentrations that correlate with clinical HF decompensations and related adverse events in at-risk HF patients. [ Time Frame: Day 5, Day 30 and Day 60 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00946231 on ClinicalTrials.gov Archive Site
To determine the feasibility of frequent home BNP self-testing with the Triage touch in the study population. [ Time Frame: Day 5, Day 30 and Day 60 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Heart Failure (HF) Assessment With B-type Natriuretic Peptide (BNP) In The Home
HF Assessment With BNP In The Home

The HABIT clinical study is being performed to determine the benefit and optimal frequency for at home testing of B-type natriuretic peptide (BNP) for heart failure patients following hospitalization from decompensation. Subjects will be enrolled following hospitalization for decompensated heart failure. Enrolled subjects will be trained on the use of the Triage Touch meter for fingerstick BNP assessment; these subjects will then test their BNP levels daily using the Triage Touch product for approximately 60 days.

This is a multi-center, single-arm double-blinded prospective clinical study to determine the optimal frequency of home B-type natriuretic peptide (BNP) testing and the changes in BNP concentrations that correlate with clinical heart failure (HF) decompensation and related adverse clinical outcomes in at-risk HF patients. Approximately 200 subjects will be enrolled.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma and Urine

Non-Probability Sample

Subjects admitted to the hospital with decompensated Heart Failure. Subjects may be enrolled while still in the hospital or within 3 days post-discharge through a heart failure clinic or other type of outpatient clinic.

Heart Failure
Not Provided
Heart Failure
Subjects admitted to the hospital with decompensated heart failure.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
187
October 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults (18 years of age or older);
  • 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:

  • Unwilling or unable to provide written informed consent;
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00946231
BSTE-0108
No
Clinical Study Manager, Biosite Incorporated
Biosite
Inverness Medical Innovations
Principal Investigator: Alan S Maisel, MD Veterans Affairs San Diego Healthcare System
Biosite
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP