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Completed

NCT Number: NCT01299350

Nt-proBNP Versus Clinical Guided Discharge in Acute Heart Failure

Our objective is to compare a policy of hospital discharge guided by NT-proBNP levels versus discharge guided by conventional clinical criteria, in patients admitted with acute heart failure. The hypothesis is that the Nt-proBNP guided discharge will shorten hospital stay without worsening the outcome

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínico Universitario

Valencia, 46010, Spain

About this study

Nt-proBNP levels as well as their response to pharmacological treatment are predictive of prognosis in patients with heart failure. The purpose of the present project is to investigate, in patients hospitalized with acute heart failure, whether a discharge decision guided by Nt-proBNP response shortens hospital stay and improves prognosis The included patients will be randomly assigned to one of these two strategies: hospital discharge according to clinical conventional criteria or discharge guided by Nt-proBNP. All patients will be treated following clinical guidelines. In the guided Nt-proBNP strategy, patients will be discharged the third day if NT-proBNP levels drops >30% compared to admission values. If such a reduction is not achieved, then the pharmacological treatment will be increased and NT-proBNP will be measured the following days until reaching the 30% reduction. In the conventional strategy, patients will be discharged at criterion of the attending cardiologist according to clinical assessment without Nt-proBNP. The main outcome will be the number of days of hospitalization at the index episode, and the secondary outcome will be death or readmission by heart failure at one and 6 months. Our hypothesis is that the Nt-proBNP guided discharge will allow to precisely evaluate the response to treatment and to determine the best time for hospital discharge. This will reduce hospital stay and death or readmission rate after discharge.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinical signs and symptoms of acute heart failure, according to the criteria of the European guidelines
  • NT-proBNP levels > 1000 pg/ml at the time of admission
  • age over 18 years old
  • signed informed consent

Exclusion criteria

  • GFR less than 30 ml/minute/m2,
  • life expectancy as determined by concomitant diseases under one year,
  • acute coronary syndrome within 10 days prior,
  • valvular heart disease with surgical approach,
  • infection or process active malignancy,
  • chronic respiratory failure with pulmonary disease.

Treatment and study plan

Nt-proBNP guided discharge

Other

Every patient will receive the drug treatment indicated in the guidelines of the European Society of Cardiology. Patients will be discharged the third day if NT-proBNP levels drops >30% compared to admission values. If such a reduction is not achieved, then the pharmacological treatment will be increased and NT-proBNP will be measured the following days until reaching the 30% reduction. The cutoff point of 30% reduction in NTproBNP was chosen based on previous studies

Primary outcomes

  1. Days of hospitalization

    Time frame: At the index episode (at discharge)

Secondary outcomes

  1. Death or readmission by heart failure

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Randomized Comparison Between Nt-proBNP or Clinical Guided Discharges in Patients Hospitalized With Acute Heart Failure

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Feb 18, 2011
Registry last updated
Apr 10, 2014

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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