Key result
Ivabradine increases the odds of significant resting heart rate reduction ~17-fold vs placebo in pediatric HF.
Why the study?
Ivabradine has shown promising efficacy for heart rate reduction in adults with heart failure, but had not been evaluated in children, leaving pediatric chronic HF recommendations based mainly on adult guidelines.
Does ivabradine reduce heart rate and improve clinical outcomes in children with dilated cardiomyopathy and symptomatic chronic heart failure?
Population
116 children with dilated cardiomyopathy and symptomatic chronic HF on stable HF therapy
Comparison
Ivabradine vs placebo
Design
Randomized, double-blind, placebo-controlled phase II/III study
Follow-up
12 months
Authors
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Enables HR reduction with ivabradine in pediatric chronic HF; extends RCT evidence to children with dilated cardiomyopathy.
RCT (n=116)
Double-blind
Does ivabradine reduce heart rate and improve clinical outcomes in children with dilated cardiomyopathy and symptomatic chronic heart failure?
Effect estimate: OR 17.24
Absolute Event Rate: 70% vs 12%
p-value: p=<0.0001
In children with dilated cardiomyopathy and symptomatic chronic heart failure, ivabradine safely reduced resting heart rate and improved left ventricular ejection fraction compared to placebo.
Bonnet et al. (2017) conducted an RCT in Dilated cardiomyopathy and symptomatic chronic heart failure (n=116). Ivabradine vs. Placebo was evaluated on ≥20% reduction in heart rate from baseline without inducing bradycardia or symptoms (OR 17.24, p=<0.0001). Ivabradine significantly increased the likelihood of achieving a ≥20% reduction in resting heart rate compared to placebo in children with chronic heart failure (70% vs 12%; OR 17.24; P<0.0001).
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