Design and baseline characteristics for the ACE Inhibitor After Anthracycline (AAA) study of cardiac dysfunction in long-term pediatric cancer survivors

Am Heart J. 2001 Oct;142(4):577-85. doi: 10.1067/mhj.2001.118115.

Abstract

Purpose: 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Age Factors
  • Algorithms
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use*
  • Anthracyclines / adverse effects*
  • Anthracyclines / therapeutic use
  • Child
  • Child, Preschool
  • Disease Progression
  • Double-Blind Method
  • Enalapril / adverse effects
  • Enalapril / therapeutic use*
  • Female
  • Heart Diseases / chemically induced*
  • Heart Diseases / diagnosis
  • Heart Diseases / prevention & control*
  • Heart Function Tests
  • Humans
  • Infant
  • Male
  • Neoplasms / drug therapy*
  • Placebos
  • Research Design / standards
  • Statistics, Nonparametric

Substances

  • Angiotensin-Converting Enzyme Inhibitors
  • Anthracyclines
  • Placebos
  • Enalapril