None listed
Conditions
Interventions
Methods:
240 patients were randomly allocated to the 1-year intervention (n=118) or usual care (n=122). The intervention consisted of nine visits with increasing intervals to a combined, intensive p
Sponsors
Funding/Support: This study was financially supported by a grant from Novartis Pharma BV, AstraZeneca BV, Bristol-Myers Squibb BV. Roche Diagnostics provided the test essays for NT-proBNP.
Role of sponsors: The funding source for this study played no role in the design or conduct of the study; data management and analysis; or manuscript preparation, review, and authorisation for submission.
Eligibility
Inclusion criteria
Inclusion criteria: The following are required at screening visit: 1. In – or out hospital patients with congestive heart failure New York Heart Association Functional Class III and IV; 2. Diagnosis of heart failure established definitely by typical clinical signs and symptoms of heart failure in conjunction with radiographic and / or echocardiographic findings of a reduced ventricular function, according to the guidelines for the diagnosis of heart failure of the European Society of Cardiology. Symptoms of heartfailure and systolic dysfunction NYHA III / IV and Left Ventricular Ejection Fraction <=45% or Symptoms of heart failure and diastolic dysfunction NYHA III/ IV; 3. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe dementia or serious psychiatric illness; 2. Discharge to a nursing home; 3. Disease other than CHF with an expected survival of less than one year (terminal illness); 4. Participation in another study; 5. Planned hospitalisation or ongoing hospitalisation; 6. Patient receiving kidney function replacement therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was the composite of hospitalisation for worsening HF and/or all cause mortality. Further, the effect on LVEF, NYHA class, quality of life, NT-proBNP, and self-care behaviour was assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional endpoints included time to (HF) hospitalization or death, utilisation of HF medication and costs of care. | — |
Contacts
Public ContactPieta W.F. Bruggink - André de la Porte
Deventer Hospital, Department of Cardiology, Fesefurstraat 7
Outcome results
None listed