Heart Failure (HF) Outpatient Monitoring Evaluation (HOME) Study

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.
• •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.