NT-proBNP in the Optimization of Treatment After Recent Acute Heart Failure Trial (BOT_AcuteHF)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Incidence of unplanned cardiovascular hospitalization and cardiac deaths at 6 months in the control and the intervention groups. [ Time Frame: 30 months ]
- 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 |
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| Italy | |
| Cardiologia, University of Brescia c/o Spedali Civili P.zza Spedali Civili 1 | |
| Brescia, BS, Italy, 25123 | |
| 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 May 21, 2013