No registrations found.
ID
Source
Brief title
Sponsors and support
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.
Intervention
Outcome measures
Primary outcome
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 outcome
Additional endpoints included time to (HF) hospitalization or death, utilisation of HF medication and costs of care.
Background summary
Conclusion: We showed that a heart failure clinic involving an intensive, protocolised intervention by both a clinician and a cardiovascular nurse, substantially reduces hospitalisations for worsening HF and/or all cause mortality and improves functional status, while decreasing health care costs, even in a country with a primary care-based health care system.
Study objective
To determine whether a regular and protocolised intervention at a heart failure (HF) clinic by a combination of a clinician and a cardiovascular nurse, both trained in HF, reduces hospitalisation for worsening HF and/or all cause mortality and improves functional status (including left ventricular ejection fraction, NYHA class and quality of life) in patients with NYHA class III or IV HF.
Study design
N/A
Intervention
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 physician-and-nurse-directed HF outpatient clinic, starting a week after hospital discharge or referral from the outpatient clinic. Verbal and written comprehensive education, optimisation of treatment, easy access to the clinic, recommendations for exercise and rest, and advice for symptom monitoring and self care were provided. Usual care included non-protocolised outpatient visits initialised by individual cardiologists in the cardiology departments involved.
Fesefurstraat 7
Pieta W.F. Bruggink - André de la Porte
Fesefurstraat 7
Deventer 7415 CM
The Netherlands
+31 (0)570 646710
p.bruggink@dz.nl
Fesefurstraat 7
Pieta W.F. Bruggink - André de la Porte
Fesefurstraat 7
Deventer 7415 CM
The Netherlands
+31 (0)570 646710
p.bruggink@dz.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL548 |
NTR-old | NTR603 |
Other | : N/A |
ISRCTN | Incomplete info ISRCTN |
Summary results
Heart failure programmes in countries with a primary care-based health care system. Are additional trials necessary? Design of the DEAL-HF study.<br>
Eur J Heart Fail. 2005 Aug;7(5):910-20. Review. <br>
PMID: 16087143 [PubMed - indexed for MEDLINE].