Better Efficacy in Lowering events by General practitioner's Intervention Using remote Monitoring in Heart Failure

ISRCTN ISRCTN34357360
DOI https://doi.org/10.1186/ISRCTN34357360
Secondary identifying numbers N/A
Submission date
30/11/2007
Registration date
29/01/2008
Last edited
29/01/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marc Castadot
Scientific

Boulevard du Jardin Botanique 32
Brussels
1000
Belgium

Study information

Study designParallel-group, prospective, single-centre, phase III, randomised controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymBELGIUM-HF Registry & Trial
Study objectivesTo 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(s)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)
Health condition(s) or problem(s) studiedSystolic heart failure
InterventionBELGIUM-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 typeOther
Primary outcome measurePrimary 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 measuresThe 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 study start date15/12/2007
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupNot Specified
Lower age limit18 Years
SexBoth
Target number of participantsRegistry: 200 patients; Randomised trial: 500 patients
Key inclusion criteriaBELGIUM-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
Key exclusion criteria1. 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
Date of first enrolment15/12/2007
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • Belgium

Study participating centre

Boulevard du Jardin Botanique 32
Brussels
1000
Belgium

Sponsor information

Saint-Jean Clinic, Department of Cardiology (Belgium)
Hospital/treatment centre

Boulevard du Jardin Botanique 32
Brussels
1000
Belgium

ROR logo "ROR" https://ror.org/01dd1x730

Funders

Funder type

Government

Institute for the Encouragement of Scientific Research and Innovation of Brussels (Public funding) (Belgium)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan