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BNP Guided Care in Addition to Multidisciplinary Care

Sponsor
Medical University of Vienna (Other)
Overall Status
Terminated
CT.gov ID
NCT00355017
Collaborator
(none)
24
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: BNP-guided care in addition to multidisciplinary management
 N/A

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
NT-BNP Guided Care in Addition to Multidisciplinary Care in Patients With Chronic Heart Failure A Three-Arm, Prospective, Randomised Study
Study Start Date :
Sep 1, 2003
Study Completion Date :
Sep 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Heart failure rehospitalisation rate; []

  2. combined endpoint death or heart failure rehospitalisation; []

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Richard Pacher, MD, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00355017
Other Study ID Numbers:
  • VF: 05.05.2003
First Posted:
Jul 20, 2006
Last Update Posted:
Oct 18, 2006
Last Verified:
Jul 1, 2006
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Oct 18, 2006