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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00355017
Other study ID # VF: 05.05.2003
Secondary ID
Status Terminated
Phase N/A
First received July 19, 2006
Last updated October 17, 2006
Start date September 2003
Est. completion date September 2005

Study information

Verified date July 2006
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and Women
Study type Interventional

Clinical Trial Summary

HF is associated with repeated hospitalisations and poor prognosis.The aim of this study is to investigate whether BNP-guided care (BGC) in addition to multidisciplinary management(MM) improves outcome compared to HNC alone or usual care (UC) for decompensated HF patients after discharge.

Patients hospitalised with cardiac decompensation in 9 Viennese hospitals are randomised to BGC, MM alone, or UC. MM includes 2 consultations of a heart failure (HF) specialist 10 days and 2 months after discharge for recommending medical optimisation and care by a specialised HF nurse including 4 home visits and telephone contact. In addition, BGC includes intensified increase of medical treatment during repeated follow-up visits in a HF clinic in patients with an Nt-BNP level above 2200pg/ml at discharge.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

1. Clinical signs and symptoms of cardiac decompensation during the present hospitalisation

2. NYHA class III or IV at time of admission

3. Cardiothoracic ratio > 0.5, and/or left ventricular ejection fraction <40% documented by echocardiography

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Procedure:
BNP-guided care in addition to multidisciplinary management


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Outcome

Type Measure Description Time frame Safety issue
Primary Heart failure rehospitalisation rate;
Primary combined endpoint death or heart failure rehospitalisation;
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