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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 28, 2014