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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
HF Outpatient Monitoring Evaluation (HOME) Study

Conditions
-----------------
Heart Failure, Systolic Heart Failure, Acute Decompensated Heart Failure

Intervention / Treatment
-----------------
* Other: Interventions with heart failure medications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18 years of age and <75 years of age); AND 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: diuretic beta blocker 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: Unwilling or unable to provide written informed consent; 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. 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 6 months due to causes other than HF or cardiovascular disease (e.g., cancer); End stage renal disease (dialysis dependency); Receiving any investigational medication; Hematocrit outside the 25 to 50% range of the HeartCheck system; Prisoner or other institutionalized or vulnerable individual; Dementia, tremors or other impediments to performing daily home BNP testing via fingerstick (unless BNP testing will be conducted by qualified caregiver); Deemed by the investigator not to be likely to comply with study-mandated procedures or instructions; Residence in regions where either transmission of test system data or home visits are not possible.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BNP + Health Management<br>Subjects will provide information from home regarding weight,signs and symptoms, and will perform BNP self testing. This information including BNP results will be used by the investigator as an aid to treatment decisions. BNP results are blinded to subjects. | Other: Interventions with heart failure medications<br>* Therapeutic interventions with heart failure medications per decision of treating physician for subjects in all study arms but using the different information available in each study arm.<br>|
| Active Comparator: Health Management<br>Subjects will provide information from home regarding weight, signs and symptoms, and will perform BNP self testing . BNP results will be blinded to the investigator and subject; weight, signs and symptoms will be used by the investigator as an aid to treatment decisions | Other: Interventions with heart failure medications<br>* Therapeutic interventions with heart failure medications per decision of treating physician for subjects in all study arms but using the different information available in each study arm.<br>|
| Placebo Comparator: Control<br>Subject will provide information from home regarding weight, signs and symptoms and will perform BNP self testing. All these data will be blinded to the investigator. BNP results will be blinded to the subject. | Other: Interventions with heart failure medications<br>* Therapeutic interventions with heart failure medications per decision of treating physician for subjects in all study arms but using the different information available in each study arm.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of hard' events per subject | With hard events defined as: HF related death, HF related readmissions to the hospitaL, IV treatment with diuretics or unusual oral diuretic change in ER Unplanned outpatient treatments for decompensated HF | Over 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fingerstick BNP test, Home Health Management System, Acute Decompensated Heart Failure, Hospital Readmission, Prevention