Nt-proBNP Versus Clinical Guided Discharge in Acute Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299350
• Other study ID #: University of Valencia
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2011
• Last updated: April 9, 2014
• Start date: November 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica del Hospital Clínico de Valencia (INCLIVA)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of hospitalization		At the index episode (at discharge)	No
Secondary	Death or readmission by heart failure		6 months	Yes