BNP Guided Care in Addition to Multidisciplinary Care - Full Text View

Sponsor:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00355017

Purpose

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	Intervention
Decompensated Heart Failure	Procedure: BNP-guided care in addition to multidisciplinary management

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Heart failure rehospitalisation rate;
combined endpoint death or heart failure rehospitalisation;

Study Start Date:	September 2003
Estimated Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical signs and symptoms of cardiac decompensation during the present hospitalisation
NYHA class III or IV at time of admission
Cardiothoracic ratio > 0.5, and/or left ventricular ejection fraction <40% documented by echocardiography

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355017

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Richard Pacher, MD

Medical University of Vienna

More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Berger R, Moertl D, Peter S, Ahmadi R, Huelsmann M, Yamuti S, Wagner B, Pacher R. N-terminal pro-B-type natriuretic peptide-guided, intensive patient management in addition to multidisciplinary care in chronic heart failure a 3-arm, prospective, randomized pilot study. J Am Coll Cardiol. 2010 Feb 16;55(7):645-53.

ClinicalTrials.gov Identifier:	NCT00355017 History of Changes
Other Study ID Numbers:	VF: 05.05.2003
Study First Received:	July 19, 2006
Last Updated:	October 17, 2006
Health Authority:	Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012