Nt-proBNP Versus Clinical Guided Discharge in Acute Heart Failure

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Other: Nt-proBNP guided discharge

• Registration Number: NCT01299350
• Lead Sponsor: University of Valencia

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Primary Completion: 2012-10
• Study Completion: 2013-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nt-proBNP guided	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

Primary Outcome Measures

Name	Time	Method
Days of hospitalization	At the index episode (at discharge)

Secondary Outcome Measures

Name	Time	Method
Death or readmission by heart failure	6 months

Trial Locations

Locations (1)

Hospital Clínico Universitario; 🇪🇸 Valencia, Spain