Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Inverness Medical Innovations | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Failure | Subjects admitted to the hospital with decompensated heart failure. |
Not provided
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan S Maisel, MD | Veterans Affairs San Diego Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Care Clinical Research Corp DBA Beaver Medical Center | Banning | California | 92220 | United States | ||
| Scripps Clinic Torrey Pines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23500322 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Plasma and Urine
| 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 |