Heart FailureHABITNCT00946231
Heart Failure (HF) Assessment With B-type Natriuretic Peptide (BNP) In The Home
An observational study of Heart Failure, run by Abbott RDx Cardiometabolic at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 187 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2009to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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);
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Care Clinical Research Corp DBA Beaver Medical Center
Banning, California, 92220
Scripps Clinic Torrey Pines
La Jolla, California, 92037
Loma Linda University Medical Center
Loma Linda, California, 92354
Loma Linda VA Medical Center
Loma Linda, California, 92357
Mission Internal Medical Group
Mission Viejo, California, 92691
St. Josephs Hospital
Orange, California, 92868
University of California Irvine Medical Center
Orange, California, 92868
Desert Cardiology Center
Rancho Mirage, California, 92270
UCSD Medical Center
San Diego, California, 92103
San Diego Cardiac Center
San Diego, California, 92123
VA- UCSD
San Diego, California, 92161
About this study
Official title: HF Assessment With BNP In The Home
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.
Read the 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.
- Conditions
- Heart Failure
- Keywords
- Heart Failure, BNP, B-type natriuretic peptide, home testing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure | Subjects admitted to the hospital with decompensated heart failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 5, Day 30 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
- Collaborators
- Inverness Medical Innovations
- Investigators
- Alan S Maisel, MD, Principal investigator, Veterans Affairs San Diego Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946231
- Sponsor's protocol ID
- BSTE-0108
- Acronym
- HABIT
- Status last verified
- Aug 2012
- First submitted
- 23 Jul 2009
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23500322
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HF Assessment With BNP In The Home
- ClinicalTrials.gov ID
- NCT00946231
- Acronym / sponsor ID
- HABIT / BSTE-0108
- Conditions
- Heart Failure
- Keywords
- Heart Failure, BNP, B-type natriuretic peptide, home testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Collaborators
- Inverness Medical Innovations
- Study start
- Jul 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure | – | –Subjects admitted to the hospital with decompensated heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
- Derived from this study: PubMed 23500322Maisel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan S Maisel, MD principal investigator
Veterans Affairs San Diego Healthcare System
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Abbott RDx Cardiometabolic at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 5, Day 30 and Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00946231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2012.