|- candidate number||1977|
|- NTR Number||NTR603|
|- ISRCTN||Incomplete info ISRCTN|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-feb-2006|
|- Secondary IDs||N/A |
|- Public Title||DEventer-ALkmaar Heart failure Project.|
|- Scientific Title||Prevention of (re)hospitalisation for heart failure and/or mortality by an intensive, protocolised intervention by both a clinician and a cardiovascular nurse in a country with a primary care-based health care system. system ( the Netherlands).|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied|
|- 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%
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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2000|
|- planned closingdate||1-apr-2004|
|- Target number of participants||240|
|- 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 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.
|- 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. |
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. Pieta W.F. Bruggink - André de la Porte|
|- CONTACT for SCIENTIFIC QUERIES||MD. Pieta W.F. Bruggink - André de la Porte|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|AstraZeneca, Novartis Pharma B.V., Bristol-Myers, Squibb, Roche Diagnostics|
|- Publications||Bruggink-Andre de la Porte PW, Lok DJ, van Wijngaarden J, Cornel JH, Pruijsers-Lamers D, van Veldhuisen DJ, Hoes AW. Related Articles, Links.|
Heart failure programmes in countries with a primary care-based health care system. Are additional trials necessary? Design of the DEAL-HF study.
Eur J Heart Fail. 2005 Aug;7(5):910-20. Review.
PMID: 16087143 [PubMed - indexed for MEDLINE].
|- Brief 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. |
|- Main changes (audit trail)|
|- RECORD||10-feb-2006 - 12-jun-2008|