S44121 vs placebo in chronic heart failure patients on a 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. A 12 week, randomised, double-blind, parallel-group, placebo controlled, international multicentre study.

• IRAS ID

  29180

• Contact name

  John Cleland

• Eudract number

  2009-011558-16

• ISRCTN Number

  requested

• Research summary

  The 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. Chronic heart failure 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 chronic heart failure. 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 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 recruited patients will each be randomly assigned to receive either a placebo or one of 4 different doses of the drug being investigated. 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 patient??s condition.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0803/44

• Date of REC Opinion

  7 May 2010

• REC opinion

  Further Information Favourable Opinion