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

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: NCT00946231
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : August 31, 2012
Sponsor:
Collaborator:
Inverness Medical Innovations
Information provided by:
Biosite

Tracking Information
First Submitted Date July 23, 2009
First Posted Date July 24, 2009
Last Update Posted Date August 31, 2012
Study Start Date July 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 23, 2009)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Heart Failure (HF) Assessment With B-type Natriuretic Peptide (BNP) In The Home
Official Title HF Assessment With BNP In The Home
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma and Urine
Sampling Method Non-Probability Sample
Study Population 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.
Condition Heart Failure
Intervention Not Provided
Study Groups/Cohorts Heart Failure
Subjects admitted to the hospital with decompensated heart failure.
Publications * 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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 30, 2012)
187
Original Estimated Enrollment
 (submitted: July 23, 2009)
200
Actual Study Completion Date October 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00946231
Other Study ID Numbers BSTE-0108
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Clinical Study Manager, Biosite Incorporated
Study Sponsor Biosite
Collaborators Inverness Medical Innovations
Investigators
Principal Investigator: Alan S Maisel, MD Veterans Affairs San Diego Healthcare System
PRS Account Biosite
Verification Date August 2012