HABIT-II: HF Assessment With BNP in the Home: Part II

• Sponsor: Alere San Diego (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02351063
• Collaborator: (none)
• Enrollment: 1
• Locations: 13
• Arm: 1
• Duration (Months): 3
• Patients Per Site: 0.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Changes of heart failure medications	N/A

Detailed Description

This is a single arm multi-center pilot study. Subjects with heart failure (HF) who are discharged following an acute decompensated heart failure (ADHF) event and subjects who are seen as outpatients with worsening signs or symptoms of HF, who meet enrollment criteria, are candidates for this study. Subjects with HF with reduced left ventricular ejection fraction (HFREF) and subjects with HF with preserved ejection fraction (HFPEF) are eligible. The eventual objective of this area of research is to demonstrate that HF subjects assisted by frequent B-type natriuretic peptide (BNP) measurements integrated into a home health management system have improved clinical outcomes. The specific objective of this study is to demonstrate that frequent BNP measurements integrated into a home health management system used by physicians to modify or intensify therapy will lead to a reduced risk of ADHF events as measured by a reduction in BNP levels. 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.

Enrollment goal is 110 evaluable subjects. Potential subjects who meet the study's inclusion and exclusion criteria will be interviewed about their interest in participating in the study. Potential subjects that show interest in the study will be judged for their willingness, ability and reliability to perform fingerstick BNP measurements every day for 180 days while at home and be able to report the results using the HeartCheck system. All qualifying subjects who agree to participate and provide Informed Consent will be trained to use the HeartCheck system which includes daily BNP measurements, daily body weight measurements, and daily health survey questions. Subjects who successfully complete their training will be judged on their proficiency in all study activities. If found to be proficient; they will use the system at home. After a short lead-in period, an algorithm (similar in concept to a moving average) will be applied to the BNP data resulting in a BNP-based parameter and alerts will be created when this parameter is rising, or during periods of sustained high BNP. The patient's physician and medical staff will be required to evaluate all BNP based alert notifications and determine if a change in HF treatment is advisable. All changes in HF treatment, with or without BNP-based alerts, are at the discretion of the treating physician and medical staff of the institution.

The primary endpoint of the study is a significant lowering of BNP across the population. At approximately 1, 3 and 6 months after enrollment, subjects will return to the clinic for physical examination, clinical assessment, and review of interval medical status by their health care provider. In addition, if warranted, a home health care professional may visit the subject at home at any time during the study when additional counseling or training may be of benefit for compliance to the protocol.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HF Assessment With BNP in the Home: Part II
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

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.

Drug: Changes of heart failure medications; Changes in dosage of existing medications or introduction of new medications to improve heart failure condition.; Other Names: Diuretics Beta blockers ACE inhibitors Angiotensin II receptor antagonists Aldosterone antagonists Vasodilators Nitrates Inotropes Other HF mediations

Outcome Measures

Primary Outcome Measures

1. Change in BNP [6 months]

   After a short lead-in period, an algorithm (similar in concept to a moving average) will be applied to the BNP data resulting in a BNP-based parameter. The primary endpoint of the study is a significant lowering of BNP across the population, such that values for the population are reduced to levels below a predetermined threshold and kept below the threshold for the duration of subsequent testing and observation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

4. Admitted to the hospital or treated in an outpatient clinic with a diagnosis of decompensated HF for which treatment will be administered; or

5. 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;

1. Increase in NYHA class with worsening symptoms (i.e. dyspnea, fatigue) at same level of activity

1. Symptoms requiring change in dosage of one or more HF medication.

2. • 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)

1. 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

2. 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

3. 400 pg/mL BNP (3200 pg/mL NT-proBNP) for subjects diagnosed with HFREF (LVSD < 40%) adjusted for BMI > 35

4. 300 pg/mL BNP (2400 pg/mL NT-proBNP) for subjects diagnosed with HFPEF (LVSD > 40%) adjusted for BMI > 35

5. Deemed willing and suitable for HeartCheck BNP home testing and participation in this study;

AND

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veterans Administration Medical Center	Loma Linda	California	United States	92357
2	Veterans Administration Medical Center	San Diego	California	United States	92161
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	Veterans Administration Medical Center	Minneapolis	Minnesota	United States	55417
5	Ohio State University Medical Center	Columbus	Ohio	United States	43210
6	Medical University of South Carolina	Charleston	South Carolina	United States	29425
7	St. Michael's Hospital	Dublin	Dun Laoghaire	Ireland
8	University Medical Center Groningen	Groningen		Netherlands
9	University of Auckland	Auckland		New Zealand
10	Christchurch Hospital	Christchurch		New Zealand
11	Universitetssjukhuset Linköping	Linköping		Sweden
12	Western Infirmary	Glasgow		United Kingdom
13	Kings College	London		United Kingdom

Sponsors and Collaborators

• Alere San Diego

Investigators

• Principal Investigator: Alan Maisel, MD, San Diego Veterans Administration Medical Center
• Principal Investigator: Ken McDonald, MD, St. Vincent's University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Januzzi JL Jr, Rehman SU, Mohammed AA, Bhardwaj A, Barajas L, Barajas J, Kim HN, Baggish AL, Weiner RB, Chen-Tournoux A, Marshall JE, Moore SA, Carlson WD, Lewis GD, Shin J, Sullivan D, Parks K, Wang TJ, Gregory SA, Uthamalingam S, Semigran MJ. Use of amino-terminal pro-B-type natriuretic peptide to guide outpatient therapy of patients with chronic left ventricular systolic dysfunction. J Am Coll Cardiol. 2011 Oct 25;58(18):1881-9. doi: 10.1016/j.jacc.2011.03.072.
• Maisel A, Barnard D, Jaski B, Frivold G, Marais J, Azer M, Miyamoto MI, Lombardo D, Kelsay D, Borden K, Iqbal N, Taub PR, Kupfer K, Clopton P, Greenberg B. Primary results of the HABIT Trial (heart failure assessment with BNP in the home). J Am Coll Cardiol. 2013 Apr 23;61(16):1726-35. doi: 10.1016/j.jacc.2013.01.052. Epub 2013 Mar 26.
• Maisel A, Mueller C, Adams K Jr, Anker SD, Aspromonte N, Cleland JG, Cohen-Solal A, Dahlstrom U, DeMaria A, Di Somma S, Filippatos GS, Fonarow GC, Jourdain P, Komajda M, Liu PP, McDonagh T, McDonald K, Mebazaa A, Nieminen MS, Peacock WF, Tubaro M, Valle R, Vanderhyden M, Yancy CW, Zannad F, Braunwald E. State of the art: using natriuretic peptide levels in clinical practice. Eur J Heart Fail. 2008 Sep;10(9):824-39. doi: 10.1016/j.ejheart.2008.07.014. Epub 2008 Aug 29. Review.
• Motiwala SR, Januzzi JL Jr. Using biomarkers to "guide" heart failure management: current perspectives and future directions. Cardiol Rev. 2013 May-Jun;21(3):127-34. doi: 10.1097/CRD.0b013e3182769073. Review.
• Troughton RW, Frampton CM, Yandle TG, Espiner EA, Nicholls MG, Richards AM. Treatment of heart failure guided by plasma aminoterminal brain natriuretic peptide (N-BNP) concentrations. Lancet. 2000 Apr 1;355(9210):1126-30.

• Responsible Party: Alere San Diego
• ClinicalTrials.gov Identifier: NCT02351063
• Other Study ID Numbers: BSTE-0144
• First Posted: Jan 30, 2015
• Last Update Posted: Feb 4, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Alere San Diego: Heart failure; BNP; home testing; remote monitoring
• Additional relevant MeSH terms: Heart Failure; Angiotensin II; Diuretics; Angiotensin-Converting Enzyme Inhibitors; Mineralocorticoid Receptor Antagonists; Angiotensin Receptor Antagonists

Study Results

Participant Flow

Arm/Group Title	Daily BNP
Arm/Group Description	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. Changes of heart failure medications: Changes in dosage of existing medications or introduction of new medications to improve heart failure condition.
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Daily BNP
Arm/Group Description	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. Changes of heart failure medications: Changes in dosage of existing medications or introduction of new medications to improve heart failure condition.
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Race and Ethnicity Not Collected () []

Outcome Measures

1. Primary Outcome

Title	Change in BNP
Description	After a short lead-in period, an algorithm (similar in concept to a moving average) will be applied to the BNP data resulting in a BNP-based parameter. The primary endpoint of the study is a significant lowering of BNP across the population, such that values for the population are reduced to levels below a predetermined threshold and kept below the threshold for the duration of subsequent testing and observation.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

One subject enrolled but no data collected. Study terminated by sponsor.

Arm/Group Title	All Subjects
Arm/Group Description	One subject enrolled but no data collected. Study terminated by sponsor.
Measure Participants	0

Adverse Events

Arm/Group Title	All Subjects
Arm/Group Description	One subject enrolled but no data collected. Study terminated by sponsor.
All Cause Mortality
	All Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.