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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 187

Contacts and Locations

Study Locations

• United States
  • California
    • Banning, California, United States, 92220
      • Care Clinical Research Corp DBA Beaver Medical Center
    • La Jolla, California, United States, 92037
      • Scripps Clinic Torrey Pines
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Loma Linda, California, United States, 92357
      • Loma Linda VA Medical Center
    • Mission Viejo, California, United States, 92691
      • Mission Internal Medical Group
    • Orange, California, United States, 92868
      • University of California Irvine Medical Center
    • Orange, California, United States, 92868
      • St. Josephs Hospital
    • Rancho Mirage, California, United States, 92270
      • Desert Cardiology Center
    • San Diego, California, United States, 92123
      • San Diego Cardiac Center
    • San Diego, California, United States, 92103
      • UCSD Medical Center
    • San Diego, California, United States, 92161
      • VA- UCSD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Heart Failure; Subjects admitted to the hospital with decompensated heart failure.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Biosite
• Collaborators: Inverness Medical Innovations
• Investigators: Principal Investigator: Alan S Maisel, MD, Veterans Affairs San Diego Healthcare System

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: July 23, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Estimate): August 31, 2012
• Last Update Submitted That Met QC Criteria: August 30, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Heart Failure; home testing; BNP; B-type natriuretic peptide
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: BSTE-0108