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Completed

NCT Number: NCT00149422

Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

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.

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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Heart Diseases Heart Failure

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universtiy Hospital Maastricht

Maastricht, Limburg, 5800, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NT-proBNP measurements

Device

Primary outcomes

  1. 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 outcomes

  1. All cause mortality

    Time frame: at least one year

  2. Cardiovascular mortality

    Time frame: at least one year

  3. All cause hospitalization

    Time frame: at least one year

  4. Cardiovascular related hospitalization

    Time frame: at least one year

  5. Total number of hospitalizations and mortality

    Time frame: at least one year

  6. Total number of cardiovascular hospitalizations and mortality

    Time frame: at least one year

  7. Differences in primary and secondary outcome measures among renal function and age subgroups

    Time frame: At least one year

  8. Differences in evidence based heart failure medication prescription after 3, 6 and 12 months

    Time frame: At least one year

  9. 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

Sponsors and collaborators

Lead sponsor

Netherlands Heart Foundation

Other

Collaborators

  • The Interuniversity Cardiology Institute of the Netherlands

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 8, 2005
Registry last updated
Feb 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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