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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498472
First Posted: July 10, 2007
Last Update Posted: June 15, 2010
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.
Information provided by:
Università degli Studi di Brescia
  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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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


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