HF Assessment With BNP in the Home: Part II

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

HABIT-II is a feasibility study aimed at home monitoring of patients with heart failure. B-type natriuretic peptide (BNP) has strong correlations to the severity of heart failure. Lower BNP levels are closely associated with better clinical outcomes. The goal of HABIT-II is to demonstrate that the results of daily patient self-testing of BNP at home will provide sufficient information to guide physicians to modify therapy and lower BNP levels over time.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alere San Diego
• Treatments: Angiotensin II; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Diuretics; Mineralocorticoid Receptor Antagonists

Criteria

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