BNP Guided Care in Addition to Multidisciplinary Care | NCT00355017

Studies
BNP Guided Care in Addition to Multidisciplinary Care

NCT00355017

Sponsor

Medical University of Vienna

Status

Terminated

Last Update Posted

Oct 18, 2006Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Decompensated Heart Failure

Interventions

BNP-guided care in addition to multidisciplinary management

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

Jul 19, 2006

First Submission Date that Met QC Criteria

Jul 19, 2006

First Posted Date

Jul 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2006

Last Update Posted Date

Oct 18, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
BNP-guided care in addition to multidisciplinary management	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart failure rehospitalisation rate;
combined endpoint death or heart failure rehospitalisation;

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Pacher, MD	Medical University of Vienna	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20170790	Derived	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.