The BATTLESCARRED trial is designed to randomize 360 patients with chronic heart failure to NTproBNP-guided treatment, clinical assessment, or usual care to evaluate effects on total mortality.
RCT (n=360)
stratified by age
Does titration of drug treatment according to plasma NTproBNP reduce total mortality in patients with chronic heart failure compared to intensive clinical assessment or usual care?
This paper describes the design of the BATTLESCARRED trial, which aims to determine if NTproBNP-guided therapy improves outcomes in chronic heart failure.
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.
Lainchbury et al. (Sat,) conducted a rct in chronic heart failure (n=360). Drug treatment directed by plasma NTproBNP vs. Intensive standardised clinical assessment or usual care was evaluated on total mortality. The BATTLESCARRED trial is designed to randomize 360 patients with chronic heart failure to NTproBNP-guided treatment, clinical assessment, or usual care to evaluate effects on total mortality.