S44121 vs placebo in chronic heart failure patients not on betablocker

• Research type

  Research Study

• Full title

  Evaluation of the effects of 4 oral dosages of S44121 versus placebo on cardiac function and NT-proBNP in patients with chronic heart failure and left ventricular dysfunction not treated with a beta-blocker. A 12 week, randomised, double-blind, parallel-group, placebo controlled, international multicentre study.

• IRAS ID

  40296

• Contact name

  John Cleland

• Sponsor organisation

  Servier Research and Development Limited

• Eudract number

  2009-011559-38

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is investigating a new drug being developed to treat patients with chronic heart failure. It will be used to look at the effect of the study drug (S44121) on the signs and symptoms of the disease. It will also help determine the most effective dose range and look at the safety profile of the drug. CHF is a term used to describe a condition characterised by the inability of the heart to pump sufficient blood around the body to meet the oxygen demands of tissues and organs. This dysfunction of the heart is responsible for patients with this condition experiencing symptoms that include tiredness, breathlessness, weakness or ankle swelling. Previous research has shown that the regulation of calcium levels within heart muscle can become disrupted in patients suffering from CHF. The drug being investigated in this study works by restoring the systems responsible for calcium regulation and thereby helping to maintain heart function. It is thought that a class of drugs called beta-blockers can indirectly improve the disrupted systems that are responsible calcium regulation. This study hopes to look at the effect of S44121 without any confounding factors, it will therefore only recruit patients who are not taking beta-blockers as part of their normal treatment. The study will be run in NHS hospitals and will recruit patients with moderate heart failure as evidenced by symptoms, echocardiographic examination and blood tests. There will be a one-week run in period followed by a twelve-week treatment period. During this time the recruits will each be randomly assigned to receive either a placebo or one of 4 different doses of S44121. The patient??s clinical progress will be assessed subjectively at different points throughout the treatment period. Echocardiography and blood tests will be performed as an objective measure of the patients condition.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/34

• Date of REC Opinion

  14 May 2010

• REC opinion

  Further Information Favourable Opinion