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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. Identifier: NCT00946231
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : August 31, 2012
Inverness Medical Innovations
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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.

Condition or disease
Heart Failure

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.

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Study Type : Observational
Actual Enrollment : 187 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: HF Assessment With BNP In The Home
Study Start Date : July 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Heart Failure
Subjects admitted to the hospital with decompensated heart failure.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
Plasma and Urine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946231

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United States, California
Care Clinical Research Corp DBA Beaver Medical Center
Banning, California, United States, 92220
Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Loma Linda VA Medical Center
Loma Linda, California, United States, 92357
Mission Internal Medical Group
Mission Viejo, California, United States, 92691
St. Josephs Hospital
Orange, California, United States, 92868
University of California Irvine Medical Center
Orange, California, United States, 92868
Desert Cardiology Center
Rancho Mirage, California, United States, 92270
UCSD Medical Center
San Diego, California, United States, 92103
San Diego Cardiac Center
San Diego, California, United States, 92123
San Diego, California, United States, 92161
Sponsors and Collaborators
Inverness Medical Innovations
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Principal Investigator: Alan S Maisel, MD Veterans Affairs San Diego Healthcare System
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Clinical Study Manager, Biosite Incorporated Identifier: NCT00946231    
Other Study ID Numbers: BSTE-0108
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012
Keywords provided by Biosite:
Heart Failure
B-type natriuretic peptide
home testing
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases