NT-proBNP in the Optimization of Treatment After Recent Acute Heart Failure Trial - Full Text View

Sponsor:	Università degli Studi di Brescia
Information provided by:	Università degli Studi di Brescia
ClinicalTrials.gov Identifier:	NCT00498472

Purpose

Hospitalizations for acute heart failure syndromes (AHFS) are associated with a high rehospitalisation and mortality rate. The aim of this study is to assess if the measurement of NT-proBNP levels before discharge may improve the prognosis of the patients recently admitted to hospital for AHFS

Condition	Intervention	Phase
Acute Heart Failure	Procedure: Pre-discharge NT-ProBNP based treatment	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	NT-proBNP in the Optimization of Treatment After Recent Acute Heart Failure (BOT-AcuteHF) Trial

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Università degli Studi di Brescia:

Primary Outcome Measures:

Incidence of unplanned cardiovascular hospitalization and cardiac deaths at 6 months in the control and the intervention groups. [ Time Frame: 30 months ]

Secondary Outcome Measures:

Cardiac mortality alone [ Time Frame: 30 months ]
Combined end-point of cardiac deaths, cardiovascular hospitalizations; no. of days in hospital during follow-up [ Time Frame: 30 months ]
Changes in LVEF, LV volumes, 6MWTD, NYHA class from discharge to 6 mts. f-up [ Time Frame: 30 months ]

Estimated Enrollment:	330
Study Start Date:	July 2006
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Pre-discharge NT-ProBNP based	Procedure: Pre-discharge NT-ProBNP based treatment Discharge date, treatment and follow-up based also on the knowledge of NT-ProBNP levels measured at 2-3 days before discharge. Discharge may be postponed and medical treatment may be changed when NT-ProBNP is >3000 pg/ml. Changes in medical treatment will include the following: increase in the diuretic dose, association of a different diuretic; combination of digoxin therapy; increase in the dose of the renin-angiotensin inhibitor; association of an ARB; association of a nitrate; short course of i.v. diuretic, vasodilator and/or inotropic therapy.
No Intervention: B Discharge date and treatment not based on the knowledge of pre-discharge NT-proBNP levels

Arms

Assigned Interventions

Active Comparator: A

Pre-discharge NT-ProBNP based

Procedure: Pre-discharge NT-ProBNP based treatment

Discharge date, treatment and follow-up based also on the knowledge of NT-ProBNP levels measured at 2-3 days before discharge.

Discharge may be postponed and medical treatment may be changed when NT-ProBNP is >3000 pg/ml. Changes in medical treatment will include the following: increase in the diuretic dose, association of a different diuretic; combination of digoxin therapy; increase in the dose of the renin-angiotensin inhibitor; association of an ARB; association of a nitrate; short course of i.v. diuretic, vasodilator and/or inotropic therapy.

No Intervention: B

Discharge date and treatment not based on the knowledge of pre-discharge NT-proBNP levels

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Patients admitted for acute HF with New York Heart Association class III or IV symptoms.
Requirement of intravenous therapy
All patients should give their written informed consent

Exclusion Criteria:

Clinical or laboratory evidence of an acute coronary syndrome
Major arrhythmias as main cause of symptoms
Patients in whom a coronary revascularization procedure (either PTCA or CABG) is planned in the next 3 months
Non cardiac concomitant diseases which may have an important influence on outcome as primary factor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498472

Locations

Italy
Cardiologia, University of Brescia c/o Spedali Civili P.zza Spedali Civili 1
Brescia, BS, Italy, 25123

Sponsors and Collaborators

Università degli Studi di Brescia

Investigators

Principal Investigator:

Marco Metra, MD

Section of Cardiovascular Disease, University of Brescia

More Information

Publications:

Metra M, Nodari S, Parrinello G, Specchia C, Brentana L, Rocca P, Fracassi F, Bordonali T, Milani P, Danesi R, Verzura G, Chiari E, Dei Cas L. The role of plasma biomarkers in acute heart failure. Serial changes and independent prognostic value of NT-proBNP and cardiac troponin-T. Eur J Heart Fail. 2007 Jun 15; [Epub ahead of print]

Bettencourt P, Azevedo A, Pimenta J, Frioes F, Ferreira S, Ferreira A. N-terminal-pro-brain natriuretic peptide predicts outcome after hospital discharge in heart failure patients. Circulation. 2004 Oct 12;110(15):2168-74. Epub 2004 Sep 27.

ClinicalTrials.gov Identifier:	NCT00498472 History of Changes
Other Study ID Numbers:	BOT_1
Study First Received:	July 9, 2007
Last Updated:	June 14, 2010
Health Authority:	Italy: Ethics Committee

Keywords provided by Università degli Studi di Brescia:

BNP
heart failure

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012