Design and baseline characteristics for the ACE Inhibitor After Anthracycline (AAA) study of cardiac dysfunction in long-term pediatric cancer survivors.
OBJECTIVE
The ACE Inhibitor After Anthracycline (AAA) study is a randomized, double-blind, controlled clinical trial comparing enalapril with placebo to determine whether treatment can slow the progression of cardiac decline in patients who screen positive for anthracycline cardiotoxicity.


METHODS
The primary outcome measure is the rate of decline, over time, in maximal cardiac index (in liters per minute per meters squared) at peak exercise; the secondary outcome measure is the rate of increase in left ventricular end systolic wall stress (in grams per centimeters squared). Patients >2 years off therapy and <4 years from diagnosis, aged 8 years and older, were eligible if they had received anthracyclines and had at least one cardiac abnormality identified at any time after anthracycline exposure.


RESULTS
A total of 135 patients were randomized to enalapril or placebo. Baseline characteristics were similar across treatment groups.


CONCLUSIONS
The AAA study will provide important information concerning the efficacy of using angiotensin-converting enzyme inhibitors to offset the effects of late anthracycline cardiotoxicity.
Silber
J H
JH
Division of Pediatric Oncology, Department of Pediatrics, Children's Hospital of Philadelphia and the University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA. Silber@email.chop.edu
Cnaan
A
A
Clark
B J
BJ
Paridon
S M
SM
Chin
A J
AJ
Rychik
J
J
Hogarty
A N
AN
Cohen
M I
MI
Barber
G
G
Rutkowsky
M
M
Kimball
T R
TR
Delaat
C
C
Steinherz
L J
LJ
Zhao
H
H
Tartaglione
M R
MR
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000465:Algorithms; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D018943:Anthracyclines / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D018450:Disease Progression; D004311:Double-Blind Method; D004656:Enalapril / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006331:Heart Diseases / Q000139:chemically induced* / Q000175:diagnosis / Q000517:prevention & control*; D006334:Heart Function Tests; D006801:Humans; D007223:Infant; D008297:Male; D009369:Neoplasms / Q000188:drug therapy*; D010919:Placebos; D012107:Research Design / Q000592:standards; D018709:Statistics, Nonparametric
D000806:Angiotensin-Converting Enzyme Inhibitors; D018943:Anthracyclines; D010919:Placebos; D004656:Enalapril