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/NCT01347567




Registration number
NCT01347567
Ethics application status
Date submitted
3/05/2011
Date registered
4/05/2011
Date last updated
3/01/2024

Titles & IDs
Public title
Heart Failure (HF) Outpatient Monitoring Evaluation (HOME) Study
Scientific title
HF Outpatient Monitoring Evaluation (HOME) Study
Secondary ID [1] 0 0
BSTE-0135
Universal Trial Number (UTN)
Trial acronym
HOME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Systolic Heart Failure 0 0
Acute Decompensated 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
Other interventions - Interventions with heart failure medications

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.

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

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: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average number of "hard' events per subject
Timepoint [1] 0 0
Over 180 days

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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
Ireland
State/province [1] 0 0
Dublin
Country [2] 0 0
Netherlands
State/province [2] 0 0
Gronongen
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch
Country [5] 0 0
Sweden
State/province [5] 0 0
Linkoping
Country [6] 0 0
United Kingdom
State/province [6] 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
Kenneth McDonald, Professor
Address 0 0
St Vincent's Private Hospitale Ltd, Dublin, Ireland
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 not provided in https://clinicaltrials.gov/study/NCT01347567