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Sponsored by: |
Università degli Studi di Brescia |
Information provided by: | Università degli Studi di Brescia |
ClinicalTrials.gov Identifier: | NCT00498472 |
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 |
MedlinePlus related topics: | Heart Failure |
ChemIDplus related topics: | Digoxin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | NT-proBNP in the Optimization of Treatment After Recent Acute Heart Failure (BOT-AcuteHF) Trial |
Estimated Enrollment: | 330 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
A: Active Comparator
Pre-discharge NT-ProBNP based
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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. |
B: No Intervention
Discharge date and treatment not based on the knowledge of pre-discharge NT-proBNP levels
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Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marco Metra, MD | 00393356460581 | metramarco@libero.it |
Contact: Livio Dei Cas, MD | 0039030307221 | deicas@unibs.it |
Italy, BS | |||||
Cardiologia, University of Brescia c/o Spedali Civili P.zza Spedali Civili 1 | Recruiting | ||||
Brescia, BS, Italy, 25123 | |||||
Contact: Marco Metra, MD +393356460581 metramarco@libero.it | |||||
Contact: Tania Bordonali, MD +393474667052 tbordonali@libero.it | |||||
Principal Investigator: Marco Metra, MD | |||||
Sub-Investigator: Rossella Danesi, MD | |||||
Sub-Investigator: Tania Bordonali, MD | |||||
Sub-Investigator: Franca Pagani, MD | |||||
Sub-Investigator: Giovanni Parinello, PhD |
Università degli Studi di Brescia |
Principal Investigator: | Marco Metra, MD | Section of Cardiovascular Disease, University of Brescia |
Study ID Numbers: | BOT_1 |
First Received: | July 9, 2007 |
Last Updated: | July 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00498472 |
Health Authority: | Italy: Ethics Committee |
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