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

This study has been completed.
Sponsor:
Information provided by:
Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT00498472
First received: July 9, 2007
Last updated: June 14, 2010
Last verified: July 2007
  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
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:


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

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
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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:
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 October 19, 2014