Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
BELGIUM-HF Registry & Trial
Study hypothesis
To test the hypothesis that general practitioner's intervention triggered by an alarm generated by an algorithm based on non-invasive vital sign home telemonitoring measurements in moderate to severe heart failure patients may reduce the rate of hospitalisations for heart failure, mortality or both.
The BELGIUM-HF Registry and Trial is a study that will be conducted in two steps.
The primary objective of the registry is to identify predictors of death, heart failure recurrence requiring hospitalisation, or both, and to validate simple and robust interventional algorithms based on weight, blood pressure and pulse transmitted by a telemonitoring system and to test those algorithms in subgroups of patients.
The primary objective of the subsequent randomised trial is to demonstrate a reduction in the incidence of Heart Failure (HF)-related hospitalisations or all-cause mortality in HF subjects managed with the the telemonitoring/interventional algorithm strategy as compared with HF subjects managed with the telemonitoring/usual care strategy over a period of 6 months.
Ethics approval
Ethics Committee for Clinical Trials at the Saint-Jean Clinic (Commission d'éthique Expérimentation Humaine de la Clinique Saint-Jean), Brussels. Date of approval: 10/10/2007 (ref: 2007-284)
Study design
Parallel-group, prospective, single-centre, phase III, randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Systolic heart failure
Intervention
BELGIUM-HF Registry: No intervention. Duration of the Registry: 6 months. Follow-up visits will take place at 3 and 6 months.
BELGIUM-HF Trial: General practitioner's intervention based on an alarm generated by a predefined algorithm applied to the telemonitoring system and based on daily measured blood pressure, pulse and weight versus usual care (control). Types of intervention: none, medication changes, cardiologist referral, out-patient clinic referral, emergency room referral, hospitalisation.
Duration of intervention: 6 months
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
Primary outcome measures in the Randomised Trial:
1. Incidence of HF-related hospitalisations (Duration of follow-up: 6 months)
2. All-cause mortality (Duration of follow-up: 6 months)
Secondary outcome measures
The following secondary end-points in the Randomised Trial will be assessed at 3 and 6 months except the cost-effectiveness evaluation, which will be carried out after the trial:
1. To demonstrate a reduction in the combined end-point of cardiac death, HF-related hospitalisations and cardiac-related urgent visits and interventions whichever comes first in HF subjects managed with the TeleMonitoring (TM) strategy compared to the Usual Care (UC) strategy
2. To demonstrate a reduction in HF-related hospitalisations in the TM arm compared to the UC arm
3. To demonstrate a reduction in all-cause mortality in the TM arm compared to the UC arm
4. To demonstrate a reduction in cardiac mortality in the TM arm compared to the UC arm
5. To demonstrate a reduction in the number of days spent at the hospital for HF-related conditions in the TM arm compared to the UC arm
6. To determine whether TM intervention improves functional status as assessed by a 6-minute walk test
7. To demonstrate an improvement in quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) in the TM arm compared to the UC arm
8. To report a shift from "in-patient" to "out-patient" healthcare utilisation in the TM arm compared to the UC arm
9. To conduct a cost-benefit comparison between the two strategies
Overall trial start date
15/12/2007
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
BELGIUM-HF will be conducted in two steps: a prospective registry and a subsequent randomised trial. The BELGIUM-HF Registry will be completed before the BELGIUM-HF Randomised Trial starts. Patients who have been included in the Registry are eligible for the subsequent randomised trial if they meet the inclusion criteria at that time and have signed an informed consent regarding the randomised trial.
Inclusion criteria for both BELGIUM-HF Registry and Randomised Trial:
1. Subject with left ventricular systolic dysfunction, defined as a left ventricular ejection fraction < or = 40%, documented by echocardiography, contrast ventriculography or radionuclide angioscintigraphy within 6 months prior to inclusion
2. Subject has been hospitalised within the past 6 months for mild to severe heart failure defined as New York Heart Association (NYHA) class II to IV
3. Subject has received loop diuretics within 2 weeks prior to inclusion
4. Subject is at least 18 years of age
5. Subject or subject's legally representative has signed and dated the study informed consent
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Registry: 200 patients; Randomised trial: 500 patients
Participant exclusion criteria
1. Subject who is scheduled for corrective valve surgery or coronary revascularisation, i.e. Coronary Artery Bypass Grafting (CABG) or Percutaneous Coronary Intervention (PCI) in a near future
2. Subject who has significant concurrent illness or condition not related to heart failure (i.e. terminal malignancy), associated with a life expectancy that is anticipated to be shorter than the expected duration of the trial
3. Subject on chronic renal dialysis
4. Pregnancy
5. Subject who has a health condition or psychic condition associated with poor compliance, including active alcoholism, mental illness or drug dependence
6. Subject directly involved in the execution of this protocol
Recruitment start date
15/12/2007
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Belgium
Trial participating centre
Boulevard du Jardin Botanique 32
Brussels
1000
Belgium
Funders
Funder type
Government
Funder name
Institute for the Encouragement of Scientific Research and Innovation of Brussels (Public funding) (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary