The pediatric randomized carvedilol trial in children with chronic heart failure: Rationale and design

Robert E. Shaddy, E. Leigh Curtin, Brett Sower, Lloyd Y. Tani, Jeri Burr, Bernard LaSalle, Mark M. Boucek, Lynn Mahony, Daphne T. Hsu, Elfriede Pahl, Grant H. Burch, Rozsa Schlencker-Herceg

Research output: Contribution to journalArticle

57 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)383-389
Number of pages7
JournalAmerican Heart Journal
Volume144
Issue number3
DOIs
StatePublished - Sep 2002
Externally publishedYes

Fingerprint

Heart Failure
Pediatrics
Ventricular Dysfunction
Pharmacokinetics
Hospitalization
carvedilol
Systolic Heart Failure
Ventricular Remodeling
Ventricular Function
Mortality
Treatment Failure
Appointments and Schedules
Placebos
Outcome Assessment (Health Care)
Parturition
Physicians
Safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Shaddy, R. E., Curtin, E. L., Sower, B., Tani, L. Y., Burr, J., LaSalle, B., ... Schlencker-Herceg, R. (2002). The pediatric randomized carvedilol trial in children with chronic heart failure: Rationale and design. American Heart Journal, 144(3), 383-389. https://doi.org/10.1067/mhj.2002.124402

The pediatric randomized carvedilol trial in children with chronic heart failure : Rationale and design. / Shaddy, Robert E.; Curtin, E. Leigh; Sower, Brett; Tani, Lloyd Y.; Burr, Jeri; LaSalle, Bernard; Boucek, Mark M.; Mahony, Lynn; Hsu, Daphne T.; Pahl, Elfriede; Burch, Grant H.; Schlencker-Herceg, Rozsa.

In: American Heart Journal, Vol. 144, No. 3, 09.2002, p. 383-389.

Research output: Contribution to journalArticle

Shaddy, RE, Curtin, EL, Sower, B, Tani, LY, Burr, J, LaSalle, B, Boucek, MM, Mahony, L, Hsu, DT, Pahl, E, Burch, GH & Schlencker-Herceg, R 2002, 'The pediatric randomized carvedilol trial in children with chronic heart failure: Rationale and design', American Heart Journal, vol. 144, no. 3, pp. 383-389. https://doi.org/10.1067/mhj.2002.124402
Shaddy, Robert E. ; Curtin, E. Leigh ; Sower, Brett ; Tani, Lloyd Y. ; Burr, Jeri ; LaSalle, Bernard ; Boucek, Mark M. ; Mahony, Lynn ; Hsu, Daphne T. ; Pahl, Elfriede ; Burch, Grant H. ; Schlencker-Herceg, Rozsa. / The pediatric randomized carvedilol trial in children with chronic heart failure : Rationale and design. In: American Heart Journal. 2002 ; Vol. 144, No. 3. pp. 383-389.
@article{cc857234dc584a89b05ccfd4ff081537,
title = "The pediatric randomized carvedilol trial in children with chronic heart failure: Rationale and design",
abstract = "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.",
author = "Shaddy, {Robert E.} and Curtin, {E. Leigh} and Brett Sower and Tani, {Lloyd Y.} and Jeri Burr and Bernard LaSalle and Boucek, {Mark M.} and Lynn Mahony and Hsu, {Daphne T.} and Elfriede Pahl and Burch, {Grant H.} and Rozsa Schlencker-Herceg",
year = "2002",
month = "9",
doi = "10.1067/mhj.2002.124402",
language = "English (US)",
volume = "144",
pages = "383--389",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "3",

}

TY - JOUR

T1 - The pediatric randomized carvedilol trial in children with chronic heart failure

T2 - Rationale and design

AU - Shaddy, Robert E.

AU - Curtin, E. Leigh

AU - Sower, Brett

AU - Tani, Lloyd Y.

AU - Burr, Jeri

AU - LaSalle, Bernard

AU - Boucek, Mark M.

AU - Mahony, Lynn

AU - Hsu, Daphne T.

AU - Pahl, Elfriede

AU - Burch, Grant H.

AU - Schlencker-Herceg, Rozsa

PY - 2002/9

Y1 - 2002/9

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0036736389&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0036736389&partnerID=8YFLogxK

U2 - 10.1067/mhj.2002.124402

DO - 10.1067/mhj.2002.124402

M3 - Article

C2 - 12228773

AN - SCOPUS:0036736389

VL - 144

SP - 383

EP - 389

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 3

ER -