This Phase II (Beneficial study) trial is designed to measure the effect of alagebrium on exercise tolerance in patients with chronic heart failure (CHF). The single-site Phase II trial is being conducted at the University Medical Centre Groningen, The Netherlands and the principal investigator is Adriaan Voors, associate professor of cardiology.
The objective of the Beneficial study is to improve maximal oxygen consumption (VO2max), which is highly correlated with an improvement in myocardial function in patients with CHF. Diastolic and systolic function will be measured by tissue velocity imaging with echocardiography. The ability of alagebrium to break down advanced glycation end-product’s (AGE) will also be measured by tracking levels of carboxy-methyllysine (an AGE) in the skin using an auto-fluorescence device.
Noah Berkowitz, president and CEO of Synvista, said: “Initiating the Beneficial study is an important milestone in the development of alagebrium as a treatment for CHF. This study will involve nine months of treatment and we hope to announce results in 2009.”