Heart Failure (HF) Outpatient Monitoring Evaluation (HOME) Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alere San Diego
ClinicalTrials.gov Identifier:
NCT01347567
First received: May 3, 2011
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine if heart failure subjects whose treatment is assisted by home BNP measurements integrated into a home health management system will have better clinical outcomes than subjects whose treatment includes home health management without BNP or than subjects treated by standard care.


Condition Intervention
Heart Failure
Systolic Heart Failure
Acute Decompensated Heart Failure
Other: Interventions with heart failure medications

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: HF Outpatient Monitoring Evaluation (HOME) Study

Resource links provided by NLM:


Further study details as provided by Alere San Diego:

Primary Outcome Measures:
  • Average number of "hard' events per subject [ Time Frame: Over 180 days ] [ Designated as safety issue: No ]

    With hard events defined as:

    • HF related death,
    • HF related readmissions to the hospitaL,
    • IV treatment with diuretics or unusual oral diuretic change in ER
    • Unplanned outpatient treatments for decompensated HF


Enrollment: 145
Study Start Date: April 2011
Study Completion Date: January 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BNP + Health Management
Subjects will provide information from home regarding weight,signs and symptoms, and will perform BNP self testing. This information including BNP results will be used by the investigator as an aid to treatment decisions. BNP results are blinded to subjects.
Other: Interventions with heart failure medications
Therapeutic interventions with heart failure medications per decision of treating physician for subjects in all study arms but using the different information available in each study arm.
Active Comparator: Health Management
Subjects will provide information from home regarding weight, signs and symptoms, and will perform BNP self testing . BNP results will be blinded to the investigator and subject; weight, signs and symptoms will be used by the investigator as an aid to treatment decisions
Other: Interventions with heart failure medications
Therapeutic interventions with heart failure medications per decision of treating physician for subjects in all study arms but using the different information available in each study arm.
Placebo Comparator: Control
Subject will provide information from home regarding weight, signs and symptoms and will perform BNP self testing. All these data will be blinded to the investigator. BNP results will be blinded to the subject.
Other: Interventions with heart failure medications
Therapeutic interventions with heart failure medications per decision of treating physician for subjects in all study arms but using the different information available in each study arm.

Detailed Description:

Systolic dysfunction heart failure subjects with low ejection fraction and elevated BNP levels admitted to hospital or treated as outpatient for decompensated Heart Failure (HF) are at hight risk for recurrent decompensation and readmission. The objective of this study is to investigate if these patients may benefit from enhanced home monitoring of their HF status.

In the 3 study arms (BNP, Health Management and control groups) home fingerstick BNP levels will be obtained so that frequent data points are available for analysis of trends and variability. These results will remain blinded to the subjects in all study arms and their care providers in the health management and control arms, the investigator and staff will have access to the BNP results only for subjects in the BNP arm and will use this information to aid in therapy decisions.

Subjects are monitored for 180 days as this time period is likely sufficient to differentiate normal biological variation in BNP changes due to impending decompensation.

Patients will be assessed at Day 30,90 and 180 after randomization HF status, patient clinical outcome and treatment adjustments are recorded.

Follow-up telephone calls to subjects at 3 and 6 months after completion of home testing will be conducted in order to determine the possible long-term benefit of home health management with daily BNP testing.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults (18 years of age and <75 years of age); AND
  2. Admitted to the hospital or treated in an outpatient clinic with a diagnosis of decompensated HF for which treatment will be administered;

i. BNP > 300 pg/mL (or NT-pro-BNP > 1500 pg/mL) during hospital admission or clinic visit.

OR c. 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 of the following medications:

  1. diuretic
  2. beta blocker
  3. ACE inhibitor iii. Physical evaluation consistent with worsening HF signs (i.e. elevated JVP, ankle edema, dyspnea, abdominal distension, >4 lb or >1.8 kg weight increase in past week) iv. HF admission in last 30 days with a documented BNP > 300 pg/mL (or NT-pro-BNP > 1500 pg/mL) during or since admission AND d. Presence of left ventricular systolic dysfunction (ejection fraction <40%); e. Successfully trained and deemed proficient on how to perform a fingerstick and to use the Test System. Each subject will undergo two proficiency assessments.

    i. The first assessment will be performed at the time in which the subject is found to meet the inclusion criteria, and deemed willing, able and reliable to complete the study tasks, and following initial training on the use of the test system. Successful completion of this first proficiency assessment will result in the enrolment of the subject into the study.

    The second assessment will be performed following one week (7 days ± 2 days) of home testing to demonstrate retention of the training. Successful completion of this second proficiency assessment will result in randomization of the subject into one of the three study arms of the study. Failure to demonstrate proficiency at this second assessment will result in the withdrawal of the subject from the study.

    Exclusion criteria:

    1. Unwilling or unable to provide written informed consent;
    2. Acute coronary syndrome (ACS) that is a primary diagnosis; or secondary diagnosis that is concomitant with the primary diagnosis of decompensated HF and for which treatment will be provided.

      Note: A history of ACS is not cause for exclusion if it is not concomitant with the present decompensated HF for which admission is being made. Small elevations in cardiac troponin that are considered by the treating physician to be associated with myocardial injury due to the acute decompensated HF and not due to a concomitant ACS or myocardial infarction are not a basis for exclusion.

    3. Previous cardiac transplantation - or cardiac transplantation anticipated within 3 months;
    4. Current or planned use of a left ventricular assist device (LVAD), use of outpatient intravenous inotropic HF therapy, major surgical procedure or percutaneous coronary intervention within 3 months;
    5. Life expectancy less than 6 months due to causes other than HF or cardiovascular disease (e.g., cancer);
    6. End stage renal disease (dialysis dependency);
    7. Receiving any investigational medication;
    8. Hematocrit outside the 25 to 50% range of the HeartCheck system;
    9. Prisoner or other institutionalized or vulnerable individual;
    10. Dementia, tremors or other impediments to performing daily home BNP testing via fingerstick (unless BNP testing will be conducted by qualified caregiver);
    11. Deemed by the investigator not to be likely to comply with study-mandated procedures or instructions;
    12. Residence in regions where either transmission of test system data or home visits are not possible.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347567

Locations
Australia, Queensland
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Ireland
St Vincent's Private Hospitale LTd
Dublin, Ireland
Netherlands
University Medical Center Groningen
Gronongen, Netherlands, 9713
New Zealand
University of Auckland
Auckland, New Zealand, 1142
Department of Medicine, University of Otago
Christchurch, New Zealand
Sweden
Linkoping University Hospital
Linkoping, Sweden, 58185
United Kingdom
Royal Brompton Hospital
London, United Kingdom
Sponsors and Collaborators
Alere San Diego
Investigators
Study Director: Kenneth McDonald, Professor St Vincent's Private Hospitale Ltd, Dublin, Ireland
Principal Investigator: Henry Dargie, Professor Western Infirmary, Glasgow, UK
Principal Investigator: Theresa McDonagh, Professor Royal Brompton, London, UK
Principal Investigator: John Atherton, Professor Royal Brisbane and Women's Hospital, Herston, Australia
Principal Investigator: Henry Krum, Professor Monash University, Melbourne Australia
Principal Investigator: Richard Thoughton, Professor University of Otago, Christchurch, New Zealand
Principal Investigator: Rob Doughty, Professor University of Auckland, Victoria, New Zealand
Principal Investigator: Faiez Zannad, Professor Institut Lorrain du Coeur et des Vaisseaux, CHU Nancy, Vandoeuvre-les-Nancy, France
Principal Investigator: Ulf Dahlstrom, Professor Linkoping University Hospital, Sweden
Principal Investigator: P Van der Meer, Doctor University Medical Center Groningen, the Netherlands
Principal Investigator: Franz Kleber, Professor Klinikum Ernst von Bergmann, Akademisches Lehrankenhaus der Charite Universitätsmedizin Berlin, Germany
  More Information

No publications provided

Responsible Party: Alere San Diego
ClinicalTrials.gov Identifier: NCT01347567     History of Changes
Other Study ID Numbers: BSTE-0135
Study First Received: May 3, 2011
Last Updated: February 4, 2014
Health Authority: Ireland: Irish Medicines Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
New Zealand: Medsafe
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Alere San Diego:
Fingerstick BNP test
Home Health Management System
Acute Decompensated Heart Failure
Hospital Readmission
Prevention

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014