Heart Failure
Conditions
Keywords
Heart Failure, BNP, B-type natriuretic peptide, home testing
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.
Interventions
None listed
Sponsors
Inverness Medical Innovations
Abbott RDx Cardiometabolic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Day 5, Day 30 and Day 60 |
Secondary
| Measure | Time frame |
|---|---|
| To determine the feasibility of frequent home BNP self-testing with the Triage touch in the study population. | Day 5, Day 30 and Day 60 |
Countries
United States
Outcome results
None listed