NCT00355017

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2003

Typical duration for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
Last Updated

October 18, 2006

Status Verified

July 1, 2006

First QC Date

July 19, 2006

Last Update Submit

October 17, 2006

Conditions

Decompensated Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Heart failure rehospitalisation rate;

  • combined endpoint death or heart failure rehospitalisation;

Interventions

BNP-guided care in addition to multidisciplinary managementPROCEDURE

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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. doi: 10.1016/j.jacc.2009.08.078.

    PMID: 20170790DERIVED

Study Officials

  • Richard Pacher, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2006

First Posted

July 20, 2006

Study Start

September 1, 2003

Study Completion

September 1, 2005

Last Updated

October 18, 2006

Record last verified: 2006-07