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Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
NT-proBNP measurements
Sponsored by
Netherlands Heart Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure, Congestive focused on measuring NT-proBNP

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Universtiy Hospital Maastricht

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NT-proBNP guided treatment group

Clinically guided arm

Arm Description

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.

Heart failure treatment guided by clinical assessment.

Outcomes

Primary Outcome Measures

Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group.

Secondary Outcome Measures

All cause mortality
Cardiovascular mortality
All cause hospitalization
Cardiovascular related hospitalization
Total number of hospitalizations and mortality
Total number of cardiovascular hospitalizations and mortality
Differences in primary and secondary outcome measures among renal function and age subgroups
Differences in evidence based heart failure medication prescription after 3, 6 and 12 months
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

Full Information

First Posted
September 6, 2005
Last Updated
February 8, 2010
Sponsor
Netherlands Heart Foundation
Collaborators
The Interuniversity Cardiology Institute of the Netherlands
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1. Study Identification

Unique Protocol Identification Number
NCT00149422
Brief Title
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

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Netherlands Heart Foundation
Collaborators
The Interuniversity Cardiology Institute of the Netherlands

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
NT-proBNP

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
NT-proBNP guided treatment group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Clinically guided arm
Arm Type
Placebo Comparator
Arm Description
Heart failure treatment guided by clinical assessment.
Intervention Type
Device
Intervention Name(s)
NT-proBNP measurements
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
All cause mortality
Time Frame
at least one year
Title
Cardiovascular mortality
Time Frame
at least one year
Title
All cause hospitalization
Time Frame
at least one year
Title
Cardiovascular related hospitalization
Time Frame
at least one year
Title
Total number of hospitalizations and mortality
Time Frame
at least one year
Title
Total number of cardiovascular hospitalizations and mortality
Time Frame
at least one year
Title
Differences in primary and secondary outcome measures among renal function and age subgroups
Time Frame
At least one year
Title
Differences in evidence based heart failure medication prescription after 3, 6 and 12 months
Time Frame
At least one year
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dave JW van Kraaij, MD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universtiy Hospital Maastricht
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
5800
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21144969
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.
Results Reference
derived
Links:
URL
http://www.acc.org/media/acc_scientific_session_09/press/sunday/ACC09Eurlings_930.pdf
Description
Interview PRIMA-study ACC congress Orlando 2009

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Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

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