HF Assessment With BNP in the Home: Part II (HABIT-II)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, BNP, home testing, remote monitoring
Eligibility Criteria
Inclusion Criteria:
- Adults at least 18 years of age
- Willing to sign an Informed Consent Form
Ambulatory subjects with worsening HF defined as:
- Admitted to the hospital or treated in an outpatient clinic with a diagnosis of decompensated HF for which treatment will be administered; or
- 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)
- 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
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
- 400 pg/mL BNP (3200 pg/mL NT-proBNP) for subjects diagnosed with HFREF (LVSD < 40%) adjusted for BMI > 35
- 300 pg/mL BNP (2400 pg/mL NT-proBNP) for subjects diagnosed with HFPEF (LVSD > 40%) adjusted for BMI > 35
Deemed willing and suitable for HeartCheck BNP home testing and participation in this study;
AND
- Successfully trained and deemed proficient on how to perform a fingerstick and to use the HeartCheck system.
Exclusion Criteria:
- Primary diagnosis at presentation of the index event of Acute Coronary Syndrome (ACS) (myocardial infarction (MI) or unstable angina).
- Prior heart transplant or planned transplant within the next 3 months
- Current or planned use of left ventricular assist device (LVAD) within 3 months
- Current or planned inotrope dependent therapy within 3 months
- Current or planned percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 3 months
- Life expectancy less than 6 months for causes other than for cardiovascular reasons
- End stage renal disease (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2)
- Other misc. cardiovascular and non-cardiovascular conditions such as amyloidosis, infiltrative cardiomyopathy, peripartum cardiomyopathy unless present for at least 12 months, acute myocarditis
- Receiving investigational medications or therapy
- Hematocrit known to be outside the 25-50% range of the HeartCheck system requirements
- Deemed likely to be noncompliant with protocol by the Investigator
- Residence in regions where transmission of test data or home visits are not possible
Sites / Locations
- Veterans Administration Medical Center
- Veterans Administration Medical Center
- Massachusetts General Hospital
- Veterans Administration Medical Center
- Ohio State University Medical Center
- Medical University of South Carolina
- St. Michael's Hospital
- University Medical Center Groningen
- University of Auckland
- Christchurch Hospital
- Universitetssjukhuset Linköping
- Western Infirmary
- Kings College
Arms of the Study
Arm 1
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.