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.


OBJECTIVE
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.


CONCLUSIONS
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
John G
JG
The Christchurch Cardioendocrine Research Group, Department of Medicine, The Christchurch School of Medicine and Health Sciences, University of Otago, Christchurch, New Zealand.
Troughton
Richard W
RW
Frampton
Christopher M
CM
Yandle
Timothy G
TG
Hamid
Amjad
A
Nicholls
M Gary
MG
Richards
A Mark
AM
D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage*; D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D004656:Enalapril / Q000008:administration & dosage*; D006333:Heart Failure / Q000097:blood* / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D020097:Natriuretic Peptide, Brain / Q000097:blood*; D010446:Peptide Fragments / Q000097:blood*; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D016277:Ventricular Function, Left / Q000502:physiology
D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain; D004656:Enalapril