Heart Failure (HF) Assessment With B-type Natriuretic Peptide (BNP) In The Home (HABIT)

This study has been completed.
Sponsor:
Collaborator:
Inverness Medical Innovations
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00946231
First received: July 23, 2009
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: HF Assessment With BNP In The Home

Resource links provided by NLM:


Further study details as provided by Biosite:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma and Urine


Enrollment: 187
Study Start Date: July 2009
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Heart Failure
Subjects admitted to the hospital with decompensated heart failure.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946231

Locations
United States, California
Care Clinical Research Corp DBA Beaver Medical Center
Banning, California, United States, 92220
Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Loma Linda VA Medical Center
Loma Linda, California, United States, 92357
Mission Internal Medical Group
Mission Viejo, California, United States, 92691
St. Josephs Hospital
Orange, California, United States, 92868
University of California Irvine Medical Center
Orange, California, United States, 92868
Desert Cardiology Center
Rancho Mirage, California, United States, 92270
San Diego Cardiac Center
San Diego, California, United States, 92123
VA- UCSD
San Diego, California, United States, 92161
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
Biosite
Inverness Medical Innovations
Investigators
Principal Investigator: Alan S Maisel, MD Veterans Affairs San Diego Healthcare System
  More Information

No publications provided by Biosite

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Study Manager, Biosite Incorporated
ClinicalTrials.gov Identifier: NCT00946231     History of Changes
Other Study ID Numbers: BSTE-0108
Study First Received: July 23, 2009
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Biosite:
Heart Failure
BNP
B-type natriuretic peptide
home testing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014