Extrait

Background and study aims We intend to investigate how good new non-invasive sensors are at detecting the response of the heart and circulation to single doses of two types of drug that have been in widespread use (nitrates and hydralazine), alone and in combination, for the management of heart failure. The effects of physiological manoeuvres such as standing and leg raising on blood circulation will also be studied. The focus of this study is to assess the ability of non-invasive sensors to detect and track changes in congestion and blood circulation. Who can participate? Male and female heart failure patients aged over 18, and a control group of patients with stable coronary artery disease or high blood pressure without heart failure. What does the study involve? In the heart failure group, we will investigate the ability of non-invasive sensors to detect changes in congestion and blood circulation in response to changes in two drugs that are recommended for the management of heart failure, although not used routinely. Patients in this group will be studied on four occasions at least 72 hours apart. Each study day lasts up to about eight hours. Patients will be asked to avoid large changes in daily diet in the three days before each study period. On study days patients will be asked to take their usual morning heart failure medications apart from loop diuretics. Patients will be asked to bring their diuretic with them to be given immediately after being weighed. They will then have a 60-minute investigation period using wearable, non-invasive monitoring devices, many of which are already commercially available. Then the following drugs will be administered to the patient in a random order: 1. No extra medication. 2. A tablet of isosorbide mononitrate. 3. A tablet of hydralazine. 4. On the final study day both isosorbide mononitrate and hydralazine, unless the patient had any problems with side effects from these medicines on the previous study days, in which case this study day will be omitted. The control patients will be studied on a single occasion with their usual daily treatment withheld for 4 hours. Only physiological manoeuvres will be studied and not drug therapy. What are the possible benefits and risks of participating? Not provided. Where is the study run from? Hull York Medical School, Cottingham, UK. When is the study starting and how long is it expected to run for? The study will run from April to September 2013. Who is funding the study? European Union 7th Framework Programme (Belgium). Who is the main contact? Prof John G F Cleland [email protected]

Critère d'inclusion

• Chronic Heart Failure

Liens

• ictrp
• isrctn