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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02351063




Registration number
NCT02351063
Ethics application status
Date submitted
12/01/2015
Date registered
30/01/2015
Date last updated
4/02/2019

Titles & IDs
Public title
HF Assessment With BNP in the Home: Part II
Scientific title
HF Assessment With BNP in the Home: Part II
Secondary ID [1] 0 0
BSTE-0144
Universal Trial Number (UTN)
Trial acronym
HABIT-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Changes of heart failure medications

Experimental: Daily BNP - Subjects will be asked to test their BNP at home every day for a period of 180 days using the AlereTM HeartCheck System (the Test System). In addition to BNP, weights and signs and symptoms of HF will be collected each day of testing. The HeartCheck data is transmitted via a secure wireless protocol to the HealthCOM health monitoring portal where it is available to the medical staff. The subject's's physician and medical staff will be required to evaluate the data and determine if a change in HF treatment is advisable. All changes of heart failure medications are at the discretion of the treating physician and medical staff of the institution.


Treatment: Drugs: Changes of heart failure medications
Changes in dosage of existing medications or introduction of new medications to improve heart failure condition.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in BNP - After a short lead-in period, an algorithm (similar in concept to a moving average) will be applied to the BNP data resulting in a BNP-based parameter. The primary endpoint of the study is a significant lowering of BNP across the population, such that values for the population are reduced to levels below a predetermined threshold and kept below the threshold for the duration of subsequent testing and observation.
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
1. Adults at least 18 years of age

2. Willing to sign an Informed Consent Form

3. Ambulatory subjects with worsening HF defined as:

1. Admitted to the hospital or treated in an outpatient clinic with a diagnosis of
decompensated HF for which treatment will be administered; or

2. Seen in an outpatient setting (i.e. heart failure clinic, general practice or
cardiology office, urgent care unit) with a documented history of HF and with
signs of worsening HF condition or decompensation, where worsening HF condition
is defined as one or more of the following;

i. Increase in NYHA class with worsening symptoms (i.e. dyspnea, fatigue) at same
level of activity

ii. Symptoms requiring change in dosage of one or more HF medication.

iii. - Physical evaluation consistent with worsening HF signs (i.e. elevated jugular
vein pressure (JVP), ankle edema, dyspnea, abdominal distension, >4 lb. or >1.8 kg
weight increase in past week)

4. Must have some documented evidence of their current LVEF status as < 40% or > 40%
(preferably a determination of %LVEF) at the time they begin BNP self-testing or
within 2 months of enrollment

5. At least one BNP value during the index hospitalization or within 2 weeks of the index
visit to clinic with worsening HF that meet the following criteria

1. 400 pg/mL BNP (3200 pg/mL NT-proBNP) for subjects diagnosed with HFREF (LVSD <
40%) adjusted for BMI > 35

2. 300 pg/mL BNP (2400 pg/mL NT-proBNP) for subjects diagnosed with HFPEF (LVSD >
40%) adjusted for BMI > 35

6. Deemed willing and suitable for HeartCheck BNP home testing and participation in this
study;

AND

7. Successfully trained and deemed proficient on how to perform a fingerstick and to use
the HeartCheck system.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Primary diagnosis at presentation of the index event of Acute Coronary Syndrome (ACS)
(myocardial infarction (MI) or unstable angina).

2. Prior heart transplant or planned transplant within the next 3 months

3. Current or planned use of left ventricular assist device (LVAD) within 3 months

4. Current or planned inotrope dependent therapy within 3 months

5. Current or planned percutaneous coronary intervention (PCI) or coronary artery bypass
graft (CABG) within 3 months

6. Life expectancy less than 6 months for causes other than for cardiovascular reasons

7. End stage renal disease (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73
m2)

8. Other misc. cardiovascular and non-cardiovascular conditions such as amyloidosis,
infiltrative cardiomyopathy, peripartum cardiomyopathy unless present for at least 12
months, acute myocarditis

9. Receiving investigational medications or therapy

10. Hematocrit known to be outside the 25-50% range of the HeartCheck system requirements

11. Deemed likely to be noncompliant with protocol by the Investigator

12. Residence in regions where transmission of test data or home visits are not possible

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
Ireland
State/province [6] 0 0
Dun Laoghaire
Country [7] 0 0
Netherlands
State/province [7] 0 0
Groningen
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
New Zealand
State/province [9] 0 0
Christchurch
Country [10] 0 0
Sweden
State/province [10] 0 0
Linköping
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Glasgow
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alere San Diego
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
HABIT-II is a feasibility study aimed at home monitoring of patients with heart failure.
B-type natriuretic peptide (BNP) has strong correlations to the severity of heart failure.
Lower BNP levels are closely associated with better clinical outcomes. The goal of HABIT-II
is to demonstrate that the results of daily patient self-testing of BNP at home will provide
sufficient information to guide physicians to modify therapy and lower BNP levels over time.
Trial website
https://clinicaltrials.gov/show/NCT02351063
Trial related presentations / 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.
Januzzi JL Jr, Rehman SU, Mohammed AA, Bhardwaj A, Barajas L, Barajas J, Kim HN, Baggish AL, Weiner RB, Chen-Tournoux A, Marshall JE, Moore SA, Carlson WD, Lewis GD, Shin J, Sullivan D, Parks K, Wang TJ, Gregory SA, Uthamalingam S, Semigran MJ. Use of amino-terminal pro-B-type natriuretic peptide to guide outpatient therapy of patients with chronic left ventricular systolic dysfunction. J Am Coll Cardiol. 2011 Oct 25;58(18):1881-9. doi: 10.1016/j.jacc.2011.03.072.
Motiwala SR, Januzzi JL Jr. Using biomarkers to "guide" heart failure management: current perspectives and future directions. Cardiol Rev. 2013 May-Jun;21(3):127-34. doi: 10.1097/CRD.0b013e3182769073. Review.
Maisel A, Mueller C, Adams K Jr, Anker SD, Aspromonte N, Cleland JG, Cohen-Solal A, Dahlstrom U, DeMaria A, Di Somma S, Filippatos GS, Fonarow GC, Jourdain P, Komajda M, Liu PP, McDonagh T, McDonald K, Mebazaa A, Nieminen MS, Peacock WF, Tubaro M, Valle R, Vanderhyden M, Yancy CW, Zannad F, Braunwald E. State of the art: using natriuretic peptide levels in clinical practice. Eur J Heart Fail. 2008 Sep;10(9):824-39. doi: 10.1016/j.ejheart.2008.07.014. Epub 2008 Aug 29. Review.
Troughton RW, Frampton CM, Yandle TG, Espiner EA, Nicholls MG, Richards AM. Treatment of heart failure guided by plasma aminoterminal brain natriuretic peptide (N-BNP) concentrations. Lancet. 2000 Apr 1;355(9210):1126-30.
Public notes

Contacts
Principal investigator
Name 0 0
Alan Maisel, MD
Address 0 0
San Diego Veterans Administration Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02351063