What question did this study set out to answer?

To prospectively evaluate the clinical efficacy of carvedilol in children and adolescents with symptomatic systemic ventricular systolic dysfunction.

September 11, 2007JAMA

Carvedilol for Children and Adolescents With Heart Failure

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Why the study?

Does carvedilol improve heart failure outcomes in children and adolescents with symptomatic systolic heart failure?

Population

161 children and adolescents with symptomatic systemic ventricular systolic dysfunction from 26 US centers.

Comparison

Carvedilol twice-daily added to conventional… vs Placebo twice-daily added to conventional heart…

Design

RCT, 1:1:1 ratio to placebo, low-dose carvedilol, or high-dose carvedilol…

Follow-up

8 months

Authors

RSRobert E. ShaddyPediatric / Congenital Cardiology MBMark M. BoucekPediatric / Congenital Cardiology DHDaphne T. HsuPediatric Cardiology

Discussion

Member takes

Implication

Does not support carvedilol in pediatric systolic heart failure; leaves open efficacy questions given possible underpowering.

Key Points

To prospectively evaluate the clinical efficacy of carvedilol in children and adolescents with symptomatic systemic ventricular systolic dysfunction.
Multicenter, randomized, double-blind, placebo-controlled trial across 26 US centers enrolling 161 children and adolescents treated for 8 months (NCT00052026).
Participants were randomized (1:1:1) to twice-daily placebo, low-dose carvedilol, or high-dose carvedilol, stratified by whether the systemic ventricle was a left ventricle.
The primary composite outcome showed no significant difference between carvedilol and placebo: 56% vs 56% improved, 24% vs 30% worsened, and 19% vs 15% were unchanged (OR for worsening = 0.79; 95% CI, 0.36–1.59; P = .47).
A significant interaction emerged between treatment and ventricular morphology (P = .02), showing a beneficial trend for systemic left ventricles and a nonbeneficial trend for non-left systemic ventricles.

Structured PICO

Does carvedilol improve heart failure outcomes in children and adolescents with symptomatic systolic heart failure?

Population

161 children and adolescents with symptomatic systemic ventricular systolic dysfunction (symptomatic systolic heart failure) from 26 US centers.

Intervention

Carvedilol twice-daily (low-dose: 0.2 mg/kg per dose if weight <62.5 kg or 12.5 mg per dose if weight >=62.5 kg; high-dose: 0.4 mg/kg per dose if weight <62.5 kg or 25 mg per dose if weight >=62.5 kg) added to conventional heart failure medications for 8 months.

Comparator

Placebo twice-daily added to conventional heart failure medications for 8 months.

Outcome

Composite measure of heart failure outcomes based on the percentage of patients who improved, worsened, or were unchanged.composite

Carvedilol did not significantly improve clinical heart failure outcomes in children and adolescents with symptomatic systolic heart failure, though the trial may have been underpowered due to lower than expected event rates.

Limitations

lower than expected event rates
trial may have been underpowered

Cite This Study

Shaddy et al. (2007) studied this question.

synapsesocial.com/papers/69fcb7c44f95092fbe78f85c https://doi.org/10.1001/jama.298.10.1171

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Carvedilol for Children and Adolescents With Heart Failure

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Carvedilol for Children and Adolescents With Heart Failure

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Also Consider

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