Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

NCT ID: NCT00149422

Last Updated: 2010-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study is to determine whether NT-proBNP guided treatment of chronic congestive heart failure will reduce heart failure related morbidity and mortality compared to therapy guided by standard clinical judgement.

Detailed Description

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Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Study Groups

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NT-proBNP guided treatment group

In this group, management was guided by an individually set NT-proBNP, defined by the lowest level at discharge or 2 weeks thereafter. If NT-proBNP levels were elevated above the individually set NT-proBNP interventions were performed according to the ESC heart failure guidelines.

Group Type ACTIVE_COMPARATOR

NT-proBNP measurements

Intervention Type DEVICE

Clinically guided arm

Heart failure treatment guided by clinical assessment.

Group Type PLACEBO_COMPARATOR

NT-proBNP measurements

Intervention Type DEVICE

Interventions

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NT-proBNP measurements

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Admission because of congestive heart failure
* Elevated NT-proBNP levels on admission

Exclusion Criteria

* Life-threatening cardiac arrhythmias
* Urgent intervention
* Severe lung disease
* Presence of life threatening disease
* Signed informed consent for other study
* Mental or physical status not allowing written informed consent.
* Unwillingness to give informed consent
* Patients undergoing haemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Interuniversity Cardiology Institute of the Netherlands

OTHER_GOV

Sponsor Role collaborator

Netherlands Heart Foundation

OTHER

Sponsor Role lead

Responsible Party

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Academic Medical Center, Amsterdam

Principal Investigators

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Dave JW van Kraaij, MD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Universtiy Hospital Maastricht

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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Eurlings LW, van Pol PE, Kok WE, van Wijk S, Lodewijks-van der Bolt C, Balk AH, Lok DJ, Crijns HJ, van Kraaij DJ, de Jonge N, Meeder JG, Prins M, Pinto YM. Management of chronic heart failure guided by individual N-terminal pro-B-type natriuretic peptide targets: results of the PRIMA (Can PRo-brain-natriuretic peptide guided therapy of chronic heart failure IMprove heart fAilure morbidity and mortality?) study. J Am Coll Cardiol. 2010 Dec 14;56(25):2090-100. doi: 10.1016/j.jacc.2010.07.030.

Reference Type DERIVED
PMID: 21144969 (View on PubMed)

Related Links

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Other Identifiers

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2003B131

Identifier Type: -

Identifier Source: org_study_id

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