Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

This study has been completed.

Sponsor:

Collaborator:

The Interuniversity Cardiology Institute of the Netherlands

Information provided by:

Netherlands Heart Foundation

ClinicalTrials.gov Identifier:

NCT00149422

First received: September 6, 2005

Last updated: February 8, 2010

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

February 8, 2010

Start Date ^ICMJE

June 2004

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. [ Time Frame: minimum of one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00149422 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

All cause mortality [ Time Frame: at least one year ] [ Designated as safety issue: No ]
Cardiovascular mortality [ Time Frame: at least one year ] [ Designated as safety issue: No ]
All cause hospitalization [ Time Frame: at least one year ] [ Designated as safety issue: No ]
Cardiovascular related hospitalization [ Time Frame: at least one year ] [ Designated as safety issue: No ]
Total number of hospitalizations and mortality [ Time Frame: at least one year ] [ Designated as safety issue: No ]
Total number of cardiovascular hospitalizations and mortality [ Time Frame: at least one year ] [ Designated as safety issue: No ]
Differences in primary and secondary outcome measures among renal function and age subgroups [ Time Frame: At least one year ] [ Designated as safety issue: No ]
Differences in evidence based heart failure medication prescription after 3, 6 and 12 months [ Time Frame: At least one year ] [ Designated as safety issue: No ]
Analysis of major endpoints in patients where NT-proBNP levels were at or below the individual target level in at least 75% of all outpatient visits [ Time Frame: at least one year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

Official Title ^ICMJE

Can Pro-brain-natriuretic Peptide Guided Therapy of Chronic Heart Failure Improve Heart Failure Morbidity and Mortality?

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic

Condition ^ICMJE

Heart Failure, Congestive

Intervention ^ICMJE

Device: NT-proBNP measurements

Study Arm (s)

Active Comparator: 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.

Intervention: Device: NT-proBNP measurements
Placebo Comparator: Clinically guided arm
Heart failure treatment guided by clinical assessment.

Intervention: Device: NT-proBNP measurements

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

April 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00149422

Other Study ID Numbers ^ICMJE

2003B131

Has Data Monitoring Committee

Yes

Responsible Party

Yigal Pinto, Academic Medical Center, Amsterdam

Study Sponsor ^ICMJE

Netherlands Heart Foundation

Collaborators ^ICMJE

The Interuniversity Cardiology Institute of the Netherlands

Investigators ^ICMJE

Principal Investigator:

Dave JW van Kraaij, MD

Maastricht University Medical Center

Information Provided By

Netherlands Heart Foundation

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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