HF Assessment With BNP in the Home: Part II

This is a single arm multi-center pilot study. Subjects with heart failure (HF) who are
discharged following an acute decompensated heart failure (ADHF) event and subjects who are
seen as outpatients with worsening signs or symptoms of HF, who meet enrollment criteria, are
candidates for this study. Subjects with HF with reduced left ventricular ejection fraction
(HFREF) and subjects with HF with preserved ejection fraction (HFPEF) are eligible. The
eventual objective of this area of research is to demonstrate that HF subjects assisted by
frequent B-type natriuretic peptide (BNP) measurements integrated into a home health
management system have improved clinical outcomes. The specific objective of this study is to
demonstrate that frequent BNP measurements integrated into a home health management system
used by physicians to modify or intensify therapy will lead to a reduced risk of ADHF events
as measured by a reduction in BNP levels. 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.

Enrollment goal is 110 evaluable subjects. Potential subjects who meet the study's inclusion
and exclusion criteria will be interviewed about their interest in participating in the
study. Potential subjects that show interest in the study will be judged for their
willingness, ability and reliability to perform fingerstick BNP measurements every day for
180 days while at home and be able to report the results using the HeartCheck system. All
qualifying subjects who agree to participate and provide Informed Consent will be trained to
use the HeartCheck system which includes daily BNP measurements, daily body weight
measurements, and daily health survey questions. Subjects who successfully complete their
training will be judged on their proficiency in all study activities. If found to be
proficient; they will use the system at home. 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 and alerts will be created when this parameter is rising, or during
periods of sustained high BNP. The patient's physician and medical staff will be required to
evaluate all BNP based alert notifications and determine if a change in HF treatment is
advisable. All changes in HF treatment, with or without BNP-based alerts, are at the
discretion of the treating physician and medical staff of the institution.

The primary endpoint of the study is a significant lowering of BNP across the population. At
approximately 1, 3 and 6 months after enrollment, subjects will return to the clinic for
physical examination, clinical assessment, and review of interval medical status by their
health care provider. In addition, if warranted, a home health care professional may visit
the subject at home at any time during the study when additional counseling or training may
be of benefit for compliance to the protocol.

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.

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