HF Assessment With BNP in the Home: Part II

Stopped early · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT02351063

Run by

Alere San Diego

People needed

1

Starts

2014-04-01

Expected to finish

2014-07-01

Last updated by the study team

2024-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Veterans Administration Medical Center — Loma Linda, California, United States
• Veterans Administration Medical Center — San Diego, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Veterans Administration Medical Center — Minneapolis, Minnesota, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• St. Michael's Hospital — Dublin, Dun Laoghaire, Ireland
• University Medical Center Groningen — Groningen, Netherlands
• University of Auckland — Auckland, New Zealand
• Christchurch Hospital — Christchurch, New Zealand
• Universitetssjukhuset Linköping — Linköping, Sweden
• Western Infirmary — Glasgow, United Kingdom
• Kings College — London, United Kingdom

Full record on ClinicalTrials.gov

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