The pediatric randomized carvedilol trial in children with chronic heart failure: Rationale and design
| Autor: | Elfriede Pahl, Lloyd Y. Tani, Grant H. Burch, E. Leigh Curtin, Bernie LaSalle, Rozsa Schlencker-Herceg, Robert E. Shaddy, Mark M. Boucek, Brett Sower, Lynn Mahony, Daphne T. Hsu, Jeri Burr |
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| Rok vydání: | 2002 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Heart disease Adrenergic beta-Antagonists Carbazoles Placebo Drug Administration Schedule law.invention Placebos Propanolamines Randomized controlled trial law Internal medicine Natriuretic Peptide Brain Ventricular Dysfunction medicine Humans Ventricular Function Prospective Studies Child Prospective cohort study Ventricular remodeling Carvedilol Adrenergic alpha-Antagonists Heart Failure Ventricular Remodeling business.industry Age Factors Infant Newborn Infant medicine.disease Clinical trial Treatment Outcome Child Preschool Heart failure Anesthesia Cardiology Female Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | American Heart Journal. 144:383-389 |
| ISSN: | 0002-8703 |
| DOI: | 10.1067/mhj.2002.124402 |
| Popis: | Background Carvedilol is a medication with both β-receptor and α-receptor blocking properties that has been approved for the treatment of heart failure in adults. Little is known about its safety, efficacy, pharmacokinetics, and dosing profile in children. Methods The primary objective of this study is to evaluate the efficacy of carvedilol administered twice daily for 8 months in terms of its effect compared with placebo on a composite measure of clinical outcomes in children with symptomatic systemic ventricular systolic dysfunction and heart failure. The secondary objectives are to determine the effect of carvedilol on individual components of a composite of clinical outcomes (hospitalizations for worsening heart failure, all-cause mortality and cardiovascular hospitalizations, all cause mortality, heart failure symptoms, and patient and physician global assessment); determine the effect of carvedilol on echocardiographic indices of ventricular function and remodeling; characterize the pharmacokinetics of carvedilol in pediatric patients with heart failure; characterize the effects carvedilol on neurohormonal systems; and provide data for the selection of an optimal titration schedule and daily dose of carvedilol in children with heart failure. This study will enroll 150 children between birth and 17 years of age with chronic symptomatic heart failure caused by systemic ventricular systolic dysfunction. Conclusion This study will determine whether carvedilol improves symptoms in children with heart failure as a result of systemic ventricular systolic dysfunction. The study also will provide information on echocardiographic changes of ventricular performance and neurohormonal levels in children with heart failure before and after treatment with carvedilol, in addition to pharmacokinetics of carvedilol in children. (Am Heart J 2002;144:383-9.) |
| Databáze: | OpenAIRE |
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