HF Assessment With BNP in the Home: Part II

NCT02351063 | Terminated Results DMC

• 1 other identifier: BSTE-0144
• Study Type: interventional
• Target: 1
• Locations: 6 countries
• Sites: 13

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.

Conditions

Heart Failure

Keywords

Heart failure; BNP; home testing; remote monitoring

Outcome Measures

Primary Outcomes (1)

• Change in BNP

  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.

  6 months

Study Arms (1)

Daily BNP

EXPERIMENTAL

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

Interventions

Changes of heart failure medications DRUG

Changes in dosage of existing medications or introduction of new medications to improve heart failure condition.

Also known as: Diuretics, Beta blockers, ACE inhibitors, Angiotensin II receptor antagonists, Aldosterone antagonists, Vasodilators, Nitrates, Inotropes, Other HF mediations

Daily BNP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Alere San Diego: lead

Study Sites (13)

Veterans Administration Medical Center

Loma Linda, California, 92357, United States

Location

Veterans Administration Medical Center

San Diego, California, 92161, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Veterans Administration Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

St. Michael's Hospital

Dublin, Dun Laoghaire, Ireland

Location

University Medical Center Groningen

Groningen, Netherlands

Location

University of Auckland

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Universitetssjukhuset Linköping

Linköping, Sweden

Location

Western Infirmary

Glasgow, United Kingdom

Location

Kings College

London, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 23500322 BACKGROUND

• 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.

  PMID: 22018299 BACKGROUND

• 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.

  PMID: 23032578 BACKGROUND

• 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.

  PMID: 18760965 BACKGROUND

• 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. doi: 10.1016/s0140-6736(00)02060-2.

  PMID: 10791374 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Diuretics; Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists; Mineralocorticoid Receptor Antagonists; Vasodilator Agents; Nitrates

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Diuretics, Potassium Sparing; Cardiovascular Agents; Therapeutic Uses; Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals

Results Point of Contact

• Title: William Arnold, PhD
• Organization: Alere, Inc.

william.arnold@alere.com

8588053177

Study Officials

• Alan Maisel, MD

  San Diego Veterans Administration Medical Center

  PRINCIPAL INVESTIGATOR

• Ken McDonald, MD

  St Vincent's University Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 30, 2015
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 3, 2024
• Results First Posted: February 4, 2019

Record last verified: 2023-12

Locations

SE (1); IE (1); GB (2); US (6); NL (1); NZ (2)