Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00149422
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 9, 2010
The Interuniversity Cardiology Institute of the Netherlands
Information provided by:
Netherlands Heart Foundation

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.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Device: NT-proBNP measurements Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Can Pro-brain-natriuretic Peptide Guided Therapy of Chronic Heart Failure Improve Heart Failure Morbidity and Mortality?
Study Start Date : June 2004
Actual Primary Completion Date : January 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: at least one year ]
  2. Cardiovascular mortality [ Time Frame: at least one year ]
  3. All cause hospitalization [ Time Frame: at least one year ]
  4. Cardiovascular related hospitalization [ Time Frame: at least one year ]
  5. Total number of hospitalizations and mortality [ Time Frame: at least one year ]
  6. Total number of cardiovascular hospitalizations and mortality [ Time Frame: at least one year ]
  7. Differences in primary and secondary outcome measures among renal function and age subgroups [ Time Frame: At least one year ]
  8. Differences in evidence based heart failure medication prescription after 3, 6 and 12 months [ Time Frame: At least one year ]
  9. 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 ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00149422

Universtiy Hospital Maastricht
Maastricht, Limburg, Netherlands, 5800
Sponsors and Collaborators
Netherlands Heart Foundation
The Interuniversity Cardiology Institute of the Netherlands
Principal Investigator: Dave JW van Kraaij, MD Maastricht University Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yigal Pinto, Academic Medical Center, Amsterdam Identifier: NCT00149422     History of Changes
Other Study ID Numbers: 2003B131
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: February 9, 2010
Last Verified: August 2008

Keywords provided by Netherlands Heart Foundation:

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases