HF Assessment With BNP in the Home: Part II

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT02351063
• Date of registration: 12/01/2015
• Prospective Registration: No
• Primary sponsor: Alere San Diego
• Public title: HF Assessment With BNP in the Home: Part II HABIT-II
• Scientific title: HF Assessment With BNP in the Home: Part II
• Date of first enrolment: April 2014
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT02351063
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Ireland, Netherlands, New Zealand, Sweden, United Kingdom, United States

Contacts

• Name: Alan Maisel, MD
• Affiliation: San Diego Veterans Administration Medical Center

• Name: Ken McDonald, MD
• Affiliation: St. Vincent's University Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Drug: Changes of heart failure medications

Primary Outcome(s)

Change in BNP [Time Frame: 6 months]

Secondary ID(s)

BSTE-0144

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/02/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02351063