Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

Heart Failure, Congestive Clinical Trial

Official title:

Can Pro-brain-natriuretic Peptide Guided Therapy of Chronic Heart Failure Improve Heart Failure Morbidity and Mortality?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149422
• Other study ID #: 2003B131
• Status: Completed
• Phase: N/A
• First received: September 6, 2005
• Last updated: February 8, 2010
• Start date: June 2004
• Est. completion date: April 2009

Study information

• Verified date: August 2008
• Source: Netherlands Heart Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Device:
• NT-proBNP measurements

Locations

Country	Name	City	State
Netherlands	Universtiy Hospital Maastricht	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Netherlands Heart Foundation	The Interuniversity Cardiology Institute of the Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	All cause mortality		at least one year	No
Secondary	Cardiovascular mortality		at least one year	No
Secondary	All cause hospitalization		at least one year	No
Secondary	Cardiovascular related hospitalization		at least one year	No
Secondary	Total number of hospitalizations and mortality		at least one year	No
Secondary	Total number of cardiovascular hospitalizations and mortality		at least one year	No
Secondary	Differences in primary and secondary outcome measures among renal function and age subgroups		At least one year	No
Secondary	Differences in evidence based heart failure medication prescription after 3, 6 and 12 months		At least one year	No
Secondary	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	No