Heart Failure (HF) Outpatient Monitoring Evaluation (HOME) Study
Heart Failure (HF) Outpatient Monitoring Evaluation (HOME) Study
The purpose of this study is to determine if heart failure subjects whose treatment is
 assisted by home BNP measurements integrated into a home health management system will have
 better clinical outcomes than subjects whose treatment includes home health management
 without BNP or than subjects treated by standard care.
Systolic dysfunction heart failure subjects with low ejection fraction and elevated BNP
 levels admitted to hospital or treated as outpatient for decompensated Heart Failure (HF) are
 at hight risk for recurrent decompensation and readmission. The objective of this study is to
 investigate if these patients may benefit from enhanced home monitoring of their HF status.

 In the 3 study arms (BNP, Health Management and control groups) home fingerstick BNP levels
 will be obtained so that frequent data points are available for analysis of trends and
 variability. These results will remain blinded to the subjects in all study arms and their
 care providers in the health management and control arms, the investigator and staff will
 have access to the BNP results only for subjects in the BNP arm and will use this information
 to aid in therapy decisions.

 Subjects are monitored for 180 days as this time period is likely sufficient to differentiate
 normal biological variation in BNP changes due to impending decompensation.

 Patients will be assessed at Day 30,90 and 180 after randomization HF status, patient
 clinical outcome and treatment adjustments are recorded.

 Follow-up telephone calls to subjects at 3 and 6 months after completion of home testing will
 be conducted in order to determine the possible long-term benefit of home health management
 with daily BNP testing.
Inclusion Criteria:

 1. Adults (18 years of age and <75 years of age); AND

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

 i. BNP > 300 pg/mL (or NT-pro-BNP > 1500 pg/mL) during hospital admission or clinic visit.

 OR c. 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 of the following
 medications:

 1. diuretic

 2. beta blocker

 3. ACE inhibitor iii. Physical evaluation consistent with worsening HF signs (i.e.
 elevated JVP, ankle edema, dyspnea, abdominal distension, >4 lb or >1.8 kg weight
 increase in past week) iv. HF admission in last 30 days with a documented BNP > 300
 pg/mL (or NT-pro-BNP > 1500 pg/mL) during or since admission AND d. Presence of left
 ventricular systolic dysfunction (ejection fraction <40%); e. Successfully trained and
 deemed proficient on how to perform a fingerstick and to use the Test System. Each
 subject will undergo two proficiency assessments.

 i. The first assessment will be performed at the time in which the subject is found to
 meet the inclusion criteria, and deemed willing, able and reliable to complete the
 study tasks, and following initial training on the use of the test system. Successful
 completion of this first proficiency assessment will result in the enrolment of the
 subject into the study.

 The second assessment will be performed following one week (7 days ± 2 days) of home
 testing to demonstrate retention of the training. Successful completion of this second
 proficiency assessment will result in randomization of the subject into one of the
 three study arms of the study. Failure to demonstrate proficiency at this second
 assessment will result in the withdrawal of the subject from the study.

 Exclusion criteria:

 1. Unwilling or unable to provide written informed consent;

 2. Acute coronary syndrome (ACS) that is a primary diagnosis; or secondary diagnosis
 that is concomitant with the primary diagnosis of decompensated HF and for which
 treatment will be provided.

 Note: A history of ACS is not cause 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.

 3. Previous cardiac transplantation - or cardiac transplantation anticipated within
 3 months;

 4. 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;

 5. Life expectancy less than 6 months due to causes other than HF or cardiovascular
 disease (e.g., cancer);

 6. End stage renal disease (dialysis dependency);

 7. Receiving any investigational medication;

 8. Hematocrit outside the 25 to 50% range of the HeartCheck system;

 9. Prisoner or other institutionalized or vulnerable individual;

 10. Dementia, tremors or other impediments to performing daily home BNP testing via
 fingerstick (unless BNP testing will be conducted by qualified caregiver);

 11. Deemed by the investigator not to be likely to comply with study-mandated
 procedures or instructions;

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