BNP Guided Care in Addition to Multidisciplinary Care

Decompensated Heart Failure Clinical Trial

Official title:

NT-BNP Guided Care in Addition to Multidisciplinary Care in Patients With Chronic Heart Failure A Three-Arm, Prospective, Randomised Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00355017
• Other study ID #: VF: 05.05.2003
• 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
• 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

• Decompensated Heart Failure
• Heart Failure

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;