Systolic heart failure Circulatory System Systolic heart failure
Conditions
Interventions
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
Sponsors
Saint-Jean Clinic, Department of Cardiology (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium
Outcome results
None listed