CVT 5127 Regadenoson Stress Echo Trial

• Research type

  Research Study

• Full title

  An Open-Label, Parallel-Group, Exploratory Study to Evaluate the Efficacy and Safety of 400 µg Regadenoson Bolus for Pharmacological Stress Echocardiography

• Sponsor organisation

  CV Therapeutics Inc.

• Eudract number

  2008 -003839-20

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  Echocardiography is used to diagnose coronary artery disease, usually after the heart has been made to work hard by exercising on a treadmill or by giving a drug which causes the heart to behave as if it were exercising. The drug (stress agent) that is available for this purpose is called dobutamine, but has some unwanted side effects and is complex to use. Sometimes a contrast agent is also used which shows up on the echocardiogram.This study will look at the effectiveness and safety of a single intravenous dose of a new stress agent drug called regadenoson which mimics the effect of exercise. It is expected that Regadenoson will be simpler to give and have fewer side effects than existing drugs.About 30 patients in total will be assessed. All patients will already have had a dobutamine stress echocardiogram test as part of their needed medical care. Once study consent is given patients will return for another echocardiogram either with regadenoson alone or regadenoson with low-level exercise on a treadmill or regadenoson with a contrast agent. The results of these regadenoson studies will be compared against the results of the dobutamine studies to see if the results are similiar.During the study, tests will be performed to confirm general health, including measurements of blood pressure, heart rate, ECG, routine blood and urine tests and details of current medications. These tests may be performed on the same day as the study echocardiogram or at a separate visit. Regadenoson will be given via an intravenous line in the arm. A similar, but separate, line will be inserted into the other arm and will be used to collect blood samples for drug levels and for a hormone called catecholamine or for giving the contrast agent. An echocardiogram will be performed. Follow up telephone calls will be made after 1-3 days to confirm that all is well. If the patient has an angiogram ordered by the doctor, the results of the angiogram will be collected.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  08/H1010/101

• Date of REC Opinion

  6 Jan 2009

• REC opinion

  Further Information Favourable Opinion