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NT-proBNP in the Optimization of Treatment After Recent Acute Heart Failure Trial (BOT_AcuteHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00498472
Recruitment Status : Completed
First Posted : July 10, 2007
Last Update Posted : June 15, 2010
Information provided by:
Università degli Studi di Brescia

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Heart Failure Procedure: Pre-discharge NT-ProBNP based treatment Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NT-proBNP in the Optimization of Treatment After Recent Acute Heart Failure (BOT-AcuteHF) Trial
Study Start Date : July 2006
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Cardiac mortality alone [ Time Frame: 30 months ]
  2. Combined end-point of cardiac deaths, cardiovascular hospitalizations; no. of days in hospital during follow-up [ Time Frame: 30 months ]
  3. Changes in LVEF, LV volumes, 6MWTD, NYHA class from discharge to 6 mts. f-up [ Time Frame: 30 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498472

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
Principal Investigator: Marco Metra, MD Section of Cardiovascular Disease, University of Brescia