NCT00149422

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

February 9, 2010

Status Verified

August 1, 2008

Enrollment Period

4.6 years

First QC Date

September 6, 2005

Last Update Submit

February 8, 2010

Conditions

Heart Failure, Congestive

Keywords

NT-proBNP

Outcome Measures

Primary Outcomes (1)

  • Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group.

    minimum of one year

Secondary Outcomes (9)

  • All cause mortality

    at least one year

  • Cardiovascular mortality

    at least one year

  • All cause hospitalization

    at least one year

  • Cardiovascular related hospitalization

    at least one year

  • Total number of hospitalizations and mortality

    at least one year

  • +4 more secondary outcomes

Study Arms (2)

NT-proBNP guided treatment group

ACTIVE COMPARATOR

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.

Device: NT-proBNP measurements

Clinically guided arm

PLACEBO COMPARATOR

Heart failure treatment guided by clinical assessment.

Device: NT-proBNP measurements

Interventions

NT-proBNP measurementsDEVICE
Clinically guided armNT-proBNP guided treatment group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universtiy Hospital Maastricht

Maastricht, Limburg, 5800, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 21144969DERIVED

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Dave JW van Kraaij, MD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

June 1, 2004

Primary Completion

January 1, 2009

Study Completion

April 1, 2009

Last Updated

February 9, 2010

Record last verified: 2008-08

Locations

NL(1)