NTproBNP-guided drug treatment for chronic heart failure: design and methods in the "BATTLESCARRED" trial.

BACKGROUND

How best to decide when to introduce drugs and what doses are optimal in individual patients with chronic heart failure (CHF), is unclear.

AIMS

We will determine whether titration of drug treatment according to plasma NTproBNP is superior regarding clinical outcomes to intensive standardised clinical assessment; whether either of the regimens noted above is superior to usual care; and whether age alters the relative efficacy of NTproBNP guided treatment.

METHODS

We will randomise 360 patients, stratified by age, to drug treatment directed by plasma NTproBNP, to intensive standardised clinical assessment, or to usual care. The primary outcome is total mortality, and secondary outcomes include death plus hospital admission for any cardiovascular event plus episodes of outpatient decompensated heart failure. Analyses will be conducted at the end of one and two years.

RESULTS

308 patients have been recruited, the majority being in NYHA functional class II, 60.6% being >75 years. The entry plasma NTproBNP level is 238, 50-1250 pmol/l, median and range, approximately 400-11,000 pg/ml.

CONCLUSION

We describe details of a study to test the potential utility of serial measurements of NTproBNP in adjusting the drug treatment of patients with CHF. Projected completion date is 2007.