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Nt-proBNP Versus Clinical Guided Discharge in Acute Heart Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Juan Sanchis, University of Valencia
ClinicalTrials.gov Identifier:
NCT01299350
First received: February 17, 2011
Last updated: April 25, 2013
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Heart Failure
 Other: Nt-proBNP guided discharge
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Randomized Comparison Between Nt-proBNP or Clinical Guided Discharges in Patients Hospitalized With Acute Heart Failure

Resource links provided by NLM:

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

Further study details as provided by University of Valencia:

Primary Outcome Measures:
  • Days of hospitalization [ Time Frame: At the index episode (at discharge) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death or readmission by heart failure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: November 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual
Every patient will receive the drug treatment indicated in the guidelines of the European Society of Cardiology. Patients will be discharged according to routine clinical practice based on symptoms, physical examination and other data that the cardiologist deems appropriate, except for Nt-proBNP.
Experimental: Nt-proBNP guided
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
 Other: Nt-proBNP guided discharge
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. GFR less than 30 ml/minute/m2,
  2. life expectancy as determined by concomitant diseases under one year,
  3. acute coronary syndrome within 10 days prior,
  4. valvular heart disease with surgical approach,
  5. infection or process active malignancy,
  6. chronic respiratory failure with pulmonary disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299350

Locations
Spain
Hospital Clínico Universitario
Valencia, Spain, 46010
Sponsors and Collaborators
University of Valencia
  More Information

No publications provided

Responsible Party: Juan Sanchis, Full Professor of Medicina, University of Valencia
ClinicalTrials.gov Identifier: NCT01299350     History of Changes
Other Study ID Numbers: University of Valencia
Study First Received: February 17, 2011
Last Updated: April 25, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica del Hospital Clínico de Valencia (INCLIVA)

Keywords provided by University of Valencia:
Heart failure
Nt-proBNP

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013