Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02351063




Registration number
NCT02351063
Ethics application status
Date submitted
12/01/2015
Date registered
30/01/2015
Date last updated
3/01/2024

Titles & IDs
Public title
HF Assessment With BNP in the Home: Part II
Scientific title
HF Assessment With BNP in the Home: Part II
Secondary ID [1] 0 0
BSTE-0144
Universal Trial Number (UTN)
Trial acronym
HABIT-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Changes of heart failure medications

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.


Treatment: Drugs: Changes of heart failure medications
Changes in dosage of existing medications or introduction of new medications to improve heart failure condition.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in BNP
Timepoint [1] 0 0
6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
Ireland
State/province [6] 0 0
Dun Laoghaire
Country [7] 0 0
Netherlands
State/province [7] 0 0
Groningen
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
New Zealand
State/province [9] 0 0
Christchurch
Country [10] 0 0
Sweden
State/province [10] 0 0
Linköping
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Glasgow
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alere San Diego
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alan Maisel, MD
Address 0 0
San Diego Veterans Administration Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02351063