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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

September 6, 2005
February 8, 2010
June 2004
January 2009   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00149422 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Effect of NT-proBNP Guided Treatment of Chronic Heart Failure
Can Pro-brain-natriuretic Peptide Guided Therapy of Chronic Heart Failure Improve Heart Failure Morbidity and Mortality?

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Heart Failure, Congestive
Device: NT-proBNP measurements
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
April 2009
January 2009   (final data collection date for primary outcome measure)

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)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00149422
2003B131
Yes
Yigal Pinto, Academic Medical Center, Amsterdam
Netherlands Heart Foundation
The Interuniversity Cardiology Institute of the Netherlands
Principal Investigator: Dave JW van Kraaij, MD Maastricht University Medical Center
Netherlands Heart Foundation
August 2008

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