Clinical trial NCT00946231: Heart Failure (HF) Assessment With B-type Natriuretic Peptide (BNP) In The Home
Official title: HF Assessment With BNP In The Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
BNP
B-type natriuretic peptide
home testing
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
Collaborators: name: Inverness Medical Innovations
First posted: 2009-07-24
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
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.
timeFrame: Day 5, Day 30 and Day 60
Secondary outcomes:
measure: To determine the feasibility of frequent home BNP self-testing with the Triage touch in the study population.
timeFrame: Day 5, Day 30 and Day 60
Other outcomes:
Locations:
city: Banning
country: United States
facility: Care Clinical Research Corp DBA Beaver Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda VA Medical Center
state: California
city: Mission Viejo
country: United States
facility: Mission Internal Medical Group
state: California
city: Orange
country: United States
facility: St. Josephs Hospital
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Rancho Mirage
country: United States
facility: Desert Cardiology Center
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: San Diego
country: United States
facility: VA- UCSD
state: California
Study officials:
affiliation: Veterans Affairs San Diego Healthcare System
name: Alan S Maisel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.