Heart FailureHOMENCT01347567
Heart Failure (HF) Outpatient Monitoring Evaluation (HOME) Study
A study testing Interventions with heart failure medications in people with Heart Failure and Systolic Heart Failure, run by Alere San Diego at 7 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Systolic Heart Failure, Acute Decompensated Heart Failure
- What is being tested?
- Interventions with heart failure medications
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Apr 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years of age and <75 years of age); AND
- Admitted to the hospital or treated in an outpatient clinic with a diagnosis of decompensated HF for which treatment will be administered;
- 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;
- 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:
- diuretic
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- beta blocker
- 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.
- 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.
Who cannot join
- Unwilling or unable to provide written informed consent;
- 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.
- Previous cardiac transplantation - or cardiac transplantation anticipated within 3 months;
- 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;
- Life expectancy less than 6 months due to causes other than HF or cardiovascular disease (e.g., cancer);
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- End stage renal disease (dialysis dependency);
- Receiving any investigational medication;
- Hematocrit outside the 25 to 50% range of the HeartCheck system;
- Prisoner or other institutionalized or vulnerable individual;
- Dementia, tremors or other impediments to performing daily home BNP testing via fingerstick (unless BNP testing will be conducted by qualified caregiver);
- Deemed by the investigator not to be likely to comply with study-mandated procedures or instructions;
- Residence in regions where either transmission of test system data or home visits are not possible.
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
New Zealand2 sites
University of Auckland
Auckland, 1142
Department of Medicine, University of Otago
Christchurch
Australia1 site
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
About this study
Official title: HF Outpatient Monitoring Evaluation (HOME) Study
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.
Read the 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.
- Being tested
- Interventions with heart failure medications
- Keywords
- Fingerstick BNP test, Home Health Management System, Acute Decompensated Heart Failure, Hospital Readmission, Prevention
- Medical subject headings
- Heart Failure, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventions with heart failure medicationsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| BNP + Health Management | Experimental | 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. Receives: Other: Interventions with heart failure medications |
| Health Management | Active comparator | 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 Receives: Other: Interventions with heart failure medications |
| Control | Placebo comparator | 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. Receives: Other: Interventions with heart failure medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of "hard' events per subject
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
Measured: Over 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alere San Diego
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth McDonald, Professor, Study director, St Vincent's Private Hospitale Ltd, Dublin, IrelandHenry Dargie, Professor, Principal investigator, Western Infirmary, Glasgow, UKTheresa McDonagh, Professor, Principal investigator, Royal Brompton, London, UKJohn Atherton, Professor, Principal investigator, Royal Brisbane and Women's Hospital, Herston, AustraliaHenry Krum, Professor, Principal investigator, Monash UniversityRichard Thoughton, Professor, Principal investigator, University of Otago, Christchurch, New ZealandRob Doughty, Professor, Principal investigator, University of Auckland, Victoria, New ZealandFaiez Zannad, Professor, Principal investigator, Institut Lorrain du Coeur et des Vaisseaux, CHU Nancy, Vandoeuvre-les-Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347567
- Sponsor's protocol ID
- BSTE-0135
- Acronym
- HOME
- Status last verified
- Dec 2023
- First submitted
- 3 May 2011
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HF Outpatient Monitoring Evaluation (HOME) Study
- ClinicalTrials.gov ID
- NCT01347567
- Acronym / sponsor ID
- HOME / BSTE-0135
- Keywords
- Fingerstick BNP test, Home Health Management System, Acute Decompensated Heart Failure, Hospital Readmission, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Alere San DiegoIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 4 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BNP + Health Management | Experimental | Other: Interventions with heart failure medicationsSubjects 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. |
| Health Management | Active comparator | Other: Interventions with heart failure medicationsSubjects 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 |
| Control | Placebo comparator | Other: Interventions with heart failure medicationsSubject 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults (18 years of age and <75 years of age); AND
- Admitted to the hospital or treated in an outpatient clinic with a diagnosis of decompensated HF for which treatment will be administered;
- 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;
- 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:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventions with heart failure medicationsTherapeutic 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. | Other | BNP + Health Management, Control, Health Management |
Primary outcome
Average number of "hard' events per subject
Time frame: Over 180 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth McDonald, Professor study director
St Vincent's Private Hospitale Ltd, Dublin, Ireland
Henry Dargie, Professor principal investigator
Western Infirmary, Glasgow, UK
Theresa McDonagh, Professor principal investigator
Royal Brompton, London, UK
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions with heart failure medications in people with Heart Failure and Systolic Heart Failure, run by Alere San Diego at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in New Zealand, Australia, Ireland, Netherlands, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of "hard' events per subject (time frame: Over 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.