Nt-proBNP Versus Clinical Guided Discharge in Acute Heart Failure

NCT ID: NCT01299350

Last Updated: 2014-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-03-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Nt-proBNP guided discharge

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Juan Sanchis

Full Professor of Medicina

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clínico Universitario

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

University of Valencia

Identifier Type: -

Identifier Source: org_study_id