Anti-arrhythmic effects of S44121 vs placebo in chronic heart failure

• Research type

  Research Study

• Full title

  Evaluation of the anti-arrhythmic effects of 3 oral dosages of S44121 versus placebo in patients with chronic heart failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia. A 12-week, randomised, double-blind parallel-group, placebo controlled, international multicentre study.

• IRAS ID

  43129

• Contact name

  John CAMM

• Sponsor organisation

  Servier Research and Development Limited

• Eudract number

  2009-014940-12

• ISRCTN Number

  not issued

• Research summary

  This study is investigating a new drug being developed to treat patients with chronic heart failure who are at risk of cardiac arrhythmia. The study will look at the effect of the study drug (44121) on the rate and occurrence of cardiac arrhythmias. It will also help to determine the most effective dose range and look at the safety profile of the drug. Previous research has shown that the regulation of calcium levels within heart muscle can become disrupted in patients suffering from chronic heart failure. This 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. The study will be run in NHS hospitals and will recruit patients with chronic heart failure who have received an implanted cardioverter defibrillator (ICD) for the prevention of arrhythmia. 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. The patients will then have a two-week follow-up period without study treatment to evaluate the safety after the study treatment discontinuation.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0707/27

• Date of REC Opinion

  25 May 2010

• REC opinion

  Further Information Favourable Opinion