LoneStar Heart has presented the primary six month results of its multicentre, randomised clinical trial of Algisyl-LVR, providing evidence that the cardiac hydrogel implant can prevent or reverse the symptoms of moderate to severe heart failure in patients with a dilated and weakened left ventricle. The improvement in clinical status and quality of life of the patients was consistent with reported data that demonstrates the cardiac hydrogel works by improving the failing heart’s structure and function.
CE-marked and approved for marketing in Europe, Algisyl-LVR is LoneStar Heart’s lead product for the treatment of advanced heart failure. Classified in Europe and in the USA as a medical device, it is intended to reverse heart failure progression in people who have an enlarged left ventricle. Surgically injected directly into the heart muscle, the hydrogel acts immediately as an internal scaffold to increase cardiac output, without undergoing long-term degradation.
Following extensive preclinical research and a prior clinical study carried out in Germany, the AUGMENT-HF trial was conducted at 15 centres in Italy, Germany, Romania, Australia, and the Netherlands. The study was specifically designed to determine whether treatment with Algisyl-LVR offers benefits to patients with decreasing cardiac function who are not responding to optimal drug therapy in a heart failure condition known as dilated cardiomyopathy of either ischaemic or non-ischaemic origin.
Entitled “A multicentre, randomised study assessing the efficacy of left ventricular augmentation with Algisyl-LVR in the treatment of advanced heart failure patients with ischaemic and non-ischaemic cardiomyopathy: The AUGMENT-HF study,” the presentation was made by Douglas L Mann, professor and chief, cardiovascular division of Washington University School of Medicine and cardiologist-in-chief, Barnes Jewish Hospital, St. Louis, USA, at the annual meeting of the American Heart Association’s Clinical Trial Sessions held in Chicago.
Mann, who is also a member of LoneStar Heart’s scientific advisory board, says: “The AUGMENT-HF study supports the concept that reducing ventricular wall stress in heart failure patients through the implant of Algisyl-LVR leads to improved functional capacity of the heart and corresponding clinical symptoms. We look forward to continuing to monitor the safety and the durability of this novel therapy because it represents a potential alternative that is badly needed in the treatment of advanced heart failure patients.”
The clinical trial measured various safety and efficacy endpoints to build upon the evidence of the risks and benefits of Algisyl-LVR. Of all of these parameters, peak VO2 is considered the best indicator of cardiovascular health because it correlates strongly with clinical symptoms, as well as morbidity and mortality in heart failure patients. In AUGMENT-HF, the change in peak VO2 was assessed by blinded core lab. Patients treated with Algisyl-LVR had an average improvement from 12.1 to 13.2ml/min/kg after only six months whereas patients treated with optimal drug therapy remained essentially unchanged.
Similarly, a six-minute walk test showed that Algisyl-LVR patients had an improved walking distance of 85 metres as opposed to a decrease of 15 metres in the control group. Both peak VO2 and six-minute walk test outcomes show strong statistical significance. Patient follow-up will continue for two years and additional data will be reported.
“We are presenting solid initial evidence that Algisyl-LVR can stop and reverse the deterioration of cardiac function in patients whose treatment options are very limited. In the coming months, we believe this evidence will continue to grow and gain strength as we follow up with enrolled patients and add new ones to our future studies and registry,” says Frank Ahmann, LoneStar Heart’s president and chief operating officer.