Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

February 8, 2010 updated by: Netherlands Heart Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 5800
        • Universtiy Hospital Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
minimum of one year

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: at least one year
at least one year
Cardiovascular mortality
Time Frame: at least one year
at least one year
All cause hospitalization
Time Frame: at least one year
at least one year
Cardiovascular related hospitalization
Time Frame: at least one year
at least one year
Total number of hospitalizations and mortality
Time Frame: at least one year
at least one year
Total number of cardiovascular hospitalizations and mortality
Time Frame: at least one year
at least one year
Differences in primary and secondary outcome measures among renal function and age subgroups
Time Frame: At least one year
At least one year
Differences in evidence based heart failure medication prescription after 3, 6 and 12 months
Time Frame: At least one year
At least one year
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
at least one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Netherlands Heart Foundation

Collaborators

The Interuniversity Cardiology Institute of the Netherlands

Investigators

  • Principal Investigator: Dave JW van Kraaij, MD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

February 9, 2010

Last Update Submitted That Met QC Criteria

February 8, 2010

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003B131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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