Clinical trial NCT00149422: Effect of NT-proBNP Guided Treatment of Chronic Heart Failure
Official title: Can Pro-brain-natriuretic Peptide Guided Therapy of Chronic Heart Failure Improve Heart Failure Morbidity and Mortality?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Keywords: NT-proBNP
Lead sponsor: Netherlands Heart Foundation
Sponsor class: OTHER
Collaborators: name: The Interuniversity Cardiology Institute of the Netherlands
First posted: 2005-09-08
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group.
timeFrame: minimum of one year
Secondary outcomes:
measure: All cause mortality
timeFrame: at least one year
measure: Cardiovascular mortality
timeFrame: at least one year
measure: All cause hospitalization
timeFrame: at least one year
measure: Cardiovascular related hospitalization
timeFrame: at least one year
measure: Total number of hospitalizations and mortality
timeFrame: at least one year
measure: Total number of cardiovascular hospitalizations and mortality
timeFrame: at least one year
measure: Differences in primary and secondary outcome measures among renal function and age subgroups
timeFrame: At least one year
measure: Differences in evidence based heart failure medication prescription after 3, 6 and 12 months
timeFrame: At least one year
measure: 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
timeFrame: at least one year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Universtiy Hospital Maastricht
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Dave JW van Kraaij, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.