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Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

This study has been completed.
Sponsor:
Collaborator:
The Interuniversity Cardiology Institute of the Netherlands
Information provided by:
Netherlands Heart Foundation
ClinicalTrials.gov Identifier:
NCT00149422
First received: September 6, 2005
Last updated: February 8, 2010
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention
Heart Failure, Congestive
 Device: NT-proBNP measurements

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Can Pro-brain-natriuretic Peptide Guided Therapy of Chronic Heart Failure Improve Heart Failure Morbidity and Mortality?

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Netherlands Heart Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: at least one year ] [ Designated as safety issue: No ]
  • Cardiovascular mortality [ Time Frame: at least one year ] [ Designated as safety issue: No ]
  • All cause hospitalization [ Time Frame: at least one year ] [ Designated as safety issue: No ]
  • Cardiovascular related hospitalization [ Time Frame: at least one year ] [ Designated as safety issue: No ]
  • Total number of hospitalizations and mortality [ Time Frame: at least one year ] [ Designated as safety issue: No ]
  • Total number of cardiovascular hospitalizations and mortality [ Time Frame: at least one year ] [ Designated as safety issue: No ]
  • Differences in primary and secondary outcome measures among renal function and age subgroups [ Time Frame: At least one year ] [ Designated as safety issue: No ]
  • Differences in evidence based heart failure medication prescription after 3, 6 and 12 months [ Time Frame: At least one year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Study Start Date: June 2004
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149422

Locations
Netherlands
Universtiy Hospital Maastricht
Maastricht, Limburg, Netherlands, 5800
Sponsors and Collaborators
Netherlands Heart Foundation
The Interuniversity Cardiology Institute of the Netherlands
Investigators
Principal Investigator: Dave JW van Kraaij, MD Maastricht University Medical Center
  More Information

Additional Information:
Interview PRIMA-study ACC congress Orlando 2009  This link exits the ClinicalTrials.gov site

No publications provided by Netherlands Heart Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yigal Pinto, Academic Medical Center, Amsterdam
ClinicalTrials.gov Identifier: NCT00149422     History of Changes
Other Study ID Numbers: 2003B131
Study First Received: September 6, 2005
Last Updated: February 8, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Netherlands Heart Foundation:
NT-proBNP

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013