Heart Failure (HF) Assessment With B-type Natriuretic Peptide (BNP) In The Home
HABIT
HF Assessment With BNP In The Home
1 other identifier
observational
187
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2009
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 23, 2009
CompletedFirst Posted
Study publicly available on registry
July 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedAugust 31, 2012
August 1, 2012
1.9 years
July 23, 2009
August 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Day 5, Day 30 and Day 60
Secondary Outcomes (1)
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
Study Arms (1)
Heart Failure
Subjects admitted to the hospital with decompensated heart failure.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott RDx Cardiometaboliclead
- Inverness Medical Innovationscollaborator
Study Sites (11)
Care Clinical Research Corp DBA Beaver Medical Center
Banning, California, 92220, United States
Scripps Clinic Torrey Pines
La Jolla, California, 92037, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Loma Linda VA Medical Center
Loma Linda, California, 92357, United States
Mission Internal Medical Group
Mission Viejo, California, 92691, United States
St. Josephs Hospital
Orange, California, 92868, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
Desert Cardiology Center
Rancho Mirage, California, 92270, United States
UCSD Medical Center
San Diego, California, 92103, United States
San Diego Cardiac Center
San Diego, California, 92123, United States
VA- UCSD
San Diego, California, 92161, United States
Related Publications (1)
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.
PMID: 23500322DERIVED
Biospecimen
Plasma and Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan S Maisel, MD
Veterans Affairs San Diego Healthcare System
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 23, 2009
First Posted
July 24, 2009
Study Start
July 1, 2009
Primary Completion
June 1, 2011
Study Completion
October 1, 2011
Last Updated
August 31, 2012
Record last verified: 2012-08