Ivabradine Study in Children with Chronic Heart Failure and DCM

• Research type

  Research Study

• Full title

  Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symtomatic chronic heart failure aged from 6 months to less than 18 years. A randomised, double-blind, multicentre, placebo controlled, phase II/III dose-finding study with a PK/PD characterisation and a 1 year efficacy/safety evaluation

• IRAS ID

  78883

• Contact name

  Piers Daubeney

• Sponsor organisation

  Servier Research and Development Limited

• Eudract number

  2011-001292-39

• ISRCTN Number

  ISRCTN

• Research summary

  This study uses a medicine called ivabradine which has been shown to reduce heart rate in adults. In a large study called the 'Shift' study, ivabradine treatment was used to reduce heart rate of adult patients with heart failure and was shown to reduce the number of hospital admissions and the number of deaths in these patients. The two main aims of this study in children are: (1) to assess if ivabradine can be used to treat children with heart failure who have a condition called dilated cardiomyopathy (increase in the size of the heart) and (2) to observe how the body interacts with the drug and how the drug is broken down by the body. This study aims to find the correct dose of ivabradine that reduces the child's heart rate by 20% - this is the percentage reduction in heart rate that led to the best outcomes in adult patients with heart failure. Once a 20% reduction in heart rate is obtained, the child is then treated with the same dose of ivabradine for 1 year. This study is placebo-controlled which means that patients may also receive a dummy treatment - 1 in 3 patients will receive the placebo, whilst 2 in 3 will receive the active medicine. The study also investigates how ivabradine interacts with the patients body and how the body breaks down ivabradine. This requires blood samples to be taken to measure levels of the drug. All children participating in this study must already be on 'optimal' standard treatment for their condition and will not have to stop or change any of their usual medicines.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/LO/1728

• Date of REC Opinion

  25 Nov 2011

• REC opinion

  Further Information Favourable Opinion