Nt-proBNP Versus Clinical Guided Discharge in Acute Heart Failure

NCT01299350 | Completed Phase 4

• 1 other identifier: University of Valencia
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Keywords

Heart failure; Nt-proBNP

Outcome Measures

Primary Outcomes (1)

• Days of hospitalization

  At the index episode (at discharge)

Secondary Outcomes (1)

• Death or readmission by heart failure

  6 months

Study Arms (2)

Usual

NO INTERVENTION

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.

Nt-proBNP guided

EXPERIMENTAL

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

Interventions

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

Nt-proBNP guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Hospital Clínico Universitario

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Medicina

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 18, 2011
• Study Start: November 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: March 1, 2013
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

ES (1)