Effects of S44121 vs placebo on cardiac arrhythmia in CPVT patients

• Research type

  Research Study

• Full title

  Effects of acute and chronic oral administration of S44121 versus placebo on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1. A randomised, parallel group, international multicentre study including a 8-week double-blind placebo controlled period followed by a 8-week single-blind period. Phase II exploratory study.

• IRAS ID

  94999

• Contact name

  Alexander Lyon

• Sponsor organisation

  Servier Research and Development Ltd

• Eudract number

  2011-000579-15

• ISRCTN Number

  not known

• Research summary

  This study is investigating a new drug being developed to treat patients with catecholaminergic polymorphic ventricular tachycardia (or CPVT). These patients experience heart rhythm disturbances or arrhythmia during exercise or emotional stress, and are at risk of sudden death. The mortality rate remains high with the current available treatments so a significant medical need exists for these patients. This study will look at the effect of the study drug (S44121) on the rate and occurrence of heart rhythm disturbances during exercise. It will also look at the safety profile of the drug. Patients with CPVT type 1 have a mutation of a gene that codes for the calcium regulating channel. Previous research has shown that the regulation of calcium levels within heart muscle can become disrupted in patients suffering from CPVT. The disruption of calcium regulation can lead to cardiac arrhythmias. The drug being investigated in this study works by restoring the systems responsible for calcium regulation and thereby helping to maintain heart function. This study will be run in NHS hospitals and will recruit patients with CPVT type 1 who are treated with a beta-blocker. There will be a two-week run-in period when the patient will take placebo, followed by a twelve-week treatment period. During this time the recruited patients will each be randomly assigned to receive either placebo or one of three different doses of the investigational drug. All patients will receive the investigational drug from week eight for four weeks before a final four-week follow up period to evaluate the safety after the study drug discontinuation.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/0131

• Date of REC Opinion

  21 Mar 2012

• REC opinion

  Further Information Favourable Opinion