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

Study population. We will include into the study patients admitted to our institute for AHFS with New York Heart Association (NYHA) class III or IV symptoms. All patients should have evidence of symptomatic heart failure with symptoms at rest or during minimal exercise requiring intravenous therapy.

All patients should give their written informed consent before entry into the study. Patients with clinical or laboratory evidence of an acute coronary syndrome as well as patients with major arrhythmias will be excluded if these conditions are likely to be the main cause of the symptoms. In contrast, patients with aspecific electrocardiographic ST segment changes and/or with a slight elevation of plasma troponin levels may be included as these conditions are known to be frequently associated with AHFS and it is generally not possible to establish to which extent they are the cause rather than the consequence of the hemodynamic decompensation. The patients in whom a coronary revascularization procedure (either PTCA or CABG) is planned in the next 3 months and the patients with non cardiac concomitant diseases that may influence outcome as primary factor will be excluded from the study.

Study design. Blood samples for the assessment of NT-proBNP plasma levels will be obtained in all the patients at at least two time intervals: pre-discharge (e.g. 24 to 72 hours before the planned date of discharge) and at discharge (e.g. at the day of discharge). Pre-discharge samples will be taken when the patient is clinically stable, on the same oral drugs and at the same doses which are planned to be administered after discharge.

All patients will be randomised according to a previous randomization scheme to two groups: control group, in which the results of NT-proBNP levels will be known only retrospectively, at the end of the trial; intervention group, in which the values of pre-discharge NT-proBNP plasma levels will be known by the investigator on the day after that of the blood sample.

In the intervention group, it will be possible to change medical treatment and, if needed, prolong the hospitalization, in the case that the pre-discharge NT-proBNP levels are >3000 pg/mL. This value has been associated with a 13-fold increase in mortality and heart failure rehospitalisation rates in patients recently admitted for AHFS. (Eur J Heart Fail. 2007 Jun 15; [Epub ahead of print] PMID: 17573240) The following changes of treatment will be possible: increase in the dose of the diuretic, association of a different diuretic (e.g. an aldosterone antagonist); combination of digoxin therapy; increase in the dose of the rennin-angiotensin inhibitor; association of an angiotensin receptor blocker; association of a nitrate; short course of i.v. diuretic, vasodilator and/or inotropic therapy.