Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure, Congestive
• Interventions: Device: NT-proBNP measurements

• Registration Number: NCT00149422
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Status Verified: 2008-08
• Primary Completion: 2009-01
• Study Completion: 2009-04
• Last Update Submitted: 2010-02-08
• Last Update Posted: 2010-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NT-proBNP guided treatment group	NT-proBNP measurements	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.
Clinically guided arm	NT-proBNP measurements	Heart failure treatment guided by clinical assessment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Total number of cardiovascular hospitalizations and mortality	at least one year
Differences in primary and secondary outcome measures among renal function and age subgroups	At least one year
Differences in evidence based heart failure medication prescription after 3, 6 and 12 months	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	at least one year

Trial Locations

Locations (1)

Universtiy Hospital Maastricht; 🇳🇱 Maastricht, Limburg, Netherlands